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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/NCT03495765




Registration number
NCT03495765
Ethics application status
Date submitted
3/04/2018
Date registered
12/04/2018
Date last updated
12/04/2018

Titles & IDs
Public title
To Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus
Scientific title
An Open-label, Multi-centre, 12-month Study to Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus ('CONTROL' Study)
Secondary ID [1] 0 0
Control1
Universal Trial Number (UTN)
Trial acronym
CONTROL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab

Active Comparator: Well controlled - Eligibile people with diabetic macular oedema and HBA1C < 7.5

Active Comparator: Poorly controlled - eligible people with Diabetic macular oedema and HBAIC >10.0


Treatment: Drugs: Ranibizumab
Ranibizumab 0.5mcg via intravitreal injection to study eye up to monthly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 12.
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
- Male or female patients with diabetes > 21 years of age who have signed an informed
consent

- Patients with either Type 1 or Type 2 diabetes mellitus (according to ADA or WHO
guidelines) with HbA1c levels either < 7.5% or = 10.0% at screening (visit 1) as
measured within the last 3 months.

- Patients with visual impairment due to either focal or diffuse DME in at least one eye
who are eligible for laser treatment in the opinion of the investigator. The study eye
must fulfill the following criteria at Visit 1 (if both eyes are eligible, the study
eye will be selected by the investigator, based on potential for improvement): i) BCVA
score between 73 and 39 letters, inclusively, using LogMAR visual acuity testing
charts at 4 metres (or at the equivalent appropriate testing distance for the chart
size) (approximate Snellen equivalent between 6/12 (20/40) and 6/48 (20/160); ii) the
decrease in vision is due to DME but not due to other causes, in the opinion of the
investigator

- OCT foveal centre point thickness = 350µm on Spectral Domain OCT (=300 µm on Time
domain OCT / STRATUS)

- Medication for the management of diabetes should have been stable within the 3 months
prior to randomisation
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Concomitant conditions in the study eye which could, in the opinion of the
investigator, prevent the improvement of visual acuity on study treatment

- Active intraocular inflammation (grade trace or above) in either eye

- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis,
endophthalmitis) in either eye

- History of uveitis in either eye

- Structural damage within 1 disc diameter of the center of the macula in the study eye
likely to preclude an improvement in visual acuity following the resolution of macular
oedema, including (geographic) atrophy of the retinal pigment epithelium, subretinal
fibrosis, laser scar(s), or organized hard exudates plaques

- Ocular disorders in the study eye that may confound interpretation of study results,
compromise visual acuity or require medical or surgical intervention during the
12-month study period, including retinal vascular occlusion, retinal detachment,
epiretinal membrane, macular hole, or choroidal neovascularization of any cause (e.g.,
AMD, ocular histoplasmosis, or pathologic myopia)

- Uncontrolled glaucoma in the study eye (according to investigator's judgment)

- Neovascularization of the iris in study eye

- Evidence of vitreomacular traction in study eye, shown either clinically or on OCT

- Panretinal laser photocoagulation in the study eye within 6 months (in order to
exclude patients with active proliferative disease) or focal/grid laser
photocoagulation in the study eye within 3 months prior to study entry

- Treatment with anti-angiogenic drugs: pegaptanib sodium, anecortave acetate,
bevacizumab, ranibizumab, aflibercept (VEGF-Trap) within 3 months to study eye

- Intravitreal corticosteroids in either eye within 6 months prior to randomisation

- Any intraocular surgery in the study eye within 3 months prior to randomisation

- History of vitrectomy in study eye

- Phakic study eye with a history of intravitreal corticosteroid treatment (due to the
likely late increase in secondary cataract)

- Ocular conditions in the study eye that is likely to require chronic concomitant
therapy with topical ocular or systemically administered corticosteroids

- History of disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug, that might affect the
interpretation of the results of the study, or that would renders the patient at high
risk from treatment complications

- Renal failure requiring dialysis or renal transplant OR renal insufficiency with
creatinine levels >2.0 mg/dl

- Untreated diabetes mellitus

- Severe (blood pressure systolic > 160 mmHg OR diastolic > 100 mmHg)

- Current use of or likely need for systemic medications known to be toxic to the lens,
retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine
(Plaquenil), Tamoxifen, Phenothiazines and Ethambutol

- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation

- Previous participation in any clinical studies of investigational drugs (excluding
vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of
the investigational drug, whatever is longer) prior to randomisation

- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner and women whose partners have been
sterilized by vasectomy or other means, UNLESS they are using two birth control
methods. The two methods can be a double barrier method or a barrier method plus a
hormonal method. Adequate barrier methods of contraception include: diaphragm, condom
(by the partner), intrauterine device (copper or hormonal), sponge or spermicide.
Hormonal contraceptives include any marketed contraceptive agent that includes an
estrogen and/or a progestational agent.

- Pregnant or nursing (lactating) women.

- Inability to comply with study or follow-up procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Marsden Eye Specialists - Paramatta
Recruitment postcode(s) [1] 0 0
2150 - Paramatta

Funding & Sponsors
Primary sponsor type
Other
Name
Marsden Eye Specialists
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in
patients with well controlled compared to those with poorly controlled diabetes using an PRN
treatment schedule.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03495765
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03495765