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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02374060
Registration number
NCT02374060
Ethics application status
Date submitted
18/02/2015
Date registered
27/02/2015
Date last updated
4/12/2018
Titles & IDs
Public title
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
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Scientific title
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
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Secondary ID [1]
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1U10EY024527-01
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Secondary ID [2]
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IRB00006139
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Universal Trial Number (UTN)
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Trial acronym
POINT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Edema
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Uveitis
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Periocular triamcinolone 40 mg
Treatment: Drugs - Intravitreal triamcinolone 4 mg
Treatment: Drugs - Dexamethasone intravitreal implant
Active Comparator: Periocular triamcinolone 40mg - Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 IF:
Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;
IOP of =21 or mm Hg and treatment with =3 IOP-lowering agents;
Active Comparator: Intravitreal triamcinolone 4mg - (preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0
Second injection permitted at Week 8 IF:
Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;
IOP of =21 or mm Hg and treatment with =3 IOP-lowering agents;
Active Comparator: Dexamethasoneintravitreal implant - Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 IF:
Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;
IOP of =21 or mm Hg and treatment with =3 IOP-lowering agents;
Treatment: Drugs: Periocular triamcinolone 40 mg
Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.
Treatment: Drugs: Intravitreal triamcinolone 4 mg
Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.
Treatment: Drugs: Dexamethasone intravitreal implant
• Standard preparation as described for intravitreal injections.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
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Assessment method [1]
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The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.
The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images.
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Timepoint [1]
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At baseline and 8 weeks
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Secondary outcome [1]
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Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
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Assessment method [1]
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The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.
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Timepoint [1]
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At baseline and the 24 week visit
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Secondary outcome [2]
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Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
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Assessment method [2]
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Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks.
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Timepoint [2]
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Over 8 weeks of follow-up
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Secondary outcome [3]
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Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
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Assessment method [3]
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Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks
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Timepoint [3]
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Over 24 weeks of follow-up
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Secondary outcome [4]
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Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
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Assessment method [4]
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Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.
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Timepoint [4]
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Over 8 weeks of follow-up
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Secondary outcome [5]
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Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
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Assessment method [5]
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Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks.
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Timepoint [5]
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Over 24 weeks of follow-up
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Secondary outcome [6]
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Change in Best-corrected Visual Acuity at 8 Weeks
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Assessment method [6]
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Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
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Timepoint [6]
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Over 8 weeks of follow-up
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Secondary outcome [7]
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Change in Best-corrected Visual Acuity at 24 Weeks
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Assessment method [7]
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Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
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Timepoint [7]
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Over 24 weeks of follow-up
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Secondary outcome [8]
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Number of Eyes With Vitreous Hemorrhage
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Assessment method [8]
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Count of eyes with vitreous hemorrhage as an immediate complication of injection.
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Timepoint [8]
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During 24 weeks of follow-up
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Secondary outcome [9]
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Number of Eyes With Retinal Tear or Detachment
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Assessment method [9]
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Count of eyes with retinal tears or detachments during the course of follow-up.
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Timepoint [9]
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During 24 weeks of follow-up
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Secondary outcome [10]
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Number of Eyes With Endophthalmitis
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Assessment method [10]
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Count of eyes with an occurrence of endophthalmitis
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Timepoint [10]
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During 24 weeks of folllow-ip
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Secondary outcome [11]
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Cumulative Proportion of Eyes With Severe Vision Loss
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Assessment method [11]
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Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up.
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Timepoint [11]
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During 24 weeks of follow-up
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Secondary outcome [12]
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Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
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Assessment method [12]
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Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up.
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Timepoint [12]
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During 24 weeks of follow-up
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Secondary outcome [13]
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Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
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Assessment method [13]
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Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up.
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Timepoint [13]
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During 24 weeks of follow-up
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Secondary outcome [14]
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Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
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Assessment method [14]
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Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up.
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Timepoint [14]
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During 24 weeks of follow-up
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Eligibility
Key inclusion criteria
Eye level inclusion criteria - at least one eye must meet all of the following conditions:
- Non-infectious anterior, intermediate, posterior or panuveitis; either active or
inactive uveitis is acceptable;
- Macular edema (ME) defined as the presence of central subfield macular thickness
greater than the normal range for the OCT machine being used, regardless of the
presence of cysts, as assessed by study ophthalmologist;
- Best corrected visual acuity (BCVA) 5/200 or better;
- Baseline intraocular pressure > 5 mm Hg and = 21 mm Hg (current use of 3 or fewer
intraocular pressure-lowering medications and/or prior glaucoma surgery are
acceptable);
- Baseline fluorescein angiogram that is gradable for leakage in the central subfield
- Pupillary dilation sufficient to allow OCT testing.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Patient level exclusion criteria:
-History of infectious uveitis, or of scleritis, keratitis, or infectious endophthalmitis
in either eye;
History of central serous retinopathy in either eye;
- For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy
test; unwilling to practice an adequate birth control method (abstinence, combination
barrier and spermicide, or hormonal) for duration of trial;
- Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
- Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose
higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose = 10
mg per day that has not been stable for at least 4 weeks(note that if patient is off
of oral prednisone at baseline (P01 visit), dose stability requirement for past 4
weeks does not apply);
- Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
- Known allergy or hypersensitivity to any component of the study drugs;
Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot
have any of the following conditions:
- History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of = 0.9
or any notching of optic nerve to the rim);
- Media opacity causing inability to assess fundus or perform OCT;
- Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of
study ophthalmologist may be significant enough to limit improvement of ME (i.e.,
causing substantial wrinkling of the retinal surface)81;
- Torn or ruptured posterior lens capsule;
- Presence of silicone oil;
- Periocular or intravitreal corticosteroid injection in past 8 weeks;
- Injection of dexamethasone intravitreal implant in past 12 weeks;
- Placement of fluocinolone acetonide implant (Retisert) in past 3 years;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/01/2018
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Sample size
Target
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Accrual to date
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Final
192
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Victorian Eye & Ear Hospital - East Melbourne
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Recruitment postcode(s) [1]
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- East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Iowa
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Country [6]
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United States of America
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State/province [6]
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Maryland
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United States of America
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Massachusetts
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United States of America
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State/province [8]
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Michigan
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Country [9]
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United States of America
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State/province [9]
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Minnesota
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Country [10]
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United States of America
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State/province [10]
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Missouri
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United States of America
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State/province [11]
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New York
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Country [12]
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United States of America
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State/province [12]
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North Carolina
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United States of America
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State/province [13]
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Pennsylvania
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Country [14]
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United States of America
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State/province [14]
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Texas
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Country [15]
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United States of America
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State/province [15]
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Utah
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Country [16]
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United States of America
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State/province [16]
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Washington
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Country [17]
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Canada
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State/province [17]
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Quebec
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Country [18]
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United Kingdom
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State/province [18]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
JHSPH Center for Clinical Trials
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Eye Institute (NEI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the
regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal
triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure
will be percent change in central subfield thickness as measured by OCT at 8 weeks.
Participants will continue in the study for 24 weeks in order to evaluate relative effects of
the 3 treatment strategies on the duration of treatment effects, requirement for additional
injections, and adverse effects.
Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192
subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned
interim analysis and recommended that the goals of the trial could be accomplished by
completing follow-up of enrolled subjects without the recruitment of additional subjects. Per
the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was
completed according to the protocol.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02374060
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Douglas A Jabs, MD, MBA
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Address
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Icahn School of Medicine, Noutn Sinai, New York, NY
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02374060
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