Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001051235
Ethics application status
Approved
Date submitted
19/10/2007
Date registered
8/12/2009
Date last updated
8/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of verteporfin (Visudyne) in combination with ranibizumab (Lucentis) for the treatment of AMD (Aged-Related Macular Degeneration) (LIV- Lucentis injection with Visudyne).
Scientific title
"Investigator initiated phase IV pilot study trial: Efficacy and safety of verteporfin (Visudyne) in combination with ranibizumab (Lucentis) for the treatment of AMD (Aged-Related Macular Degeneration) (LIV- Lucentis injection with Visudyne) in patients over 50".
Universal Trial Number (UTN)
Trial acronym
LIV - Lucentis injection with Visudyne
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AMD (Aged-Related Macular Degeneration) 2481 0
Condition category
Condition code
Eye 2582 2582 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Visudyne treatment followed by an intravitreal injection of Lucentis 0.5 mg within 2 hours (visit 1; month 0). Patients will be reviewed again at 6 weeks (visit 2) and 12 weeks (visit 3) at which time repeat intravitreal injections of Lucentis 0.5 mg will be administered. Patients will be followed up again at 6 weekly visits thereafter for a total of 12 months.
Visudyne Treatment
Visudyne will be administered as an intravenous injection of 6mg/m2 body surface area (BSA) at baseline only a maximum of 2 hours prior to the Lucentis injection.
Dosage and Administration Visudyne treatment is a two step process.
The first step is a ten minute intravenous infusion of Visudyne at a dose of 6 mg/m2 body surface area, diluted in 30 mL infusion solution.
The second step is the light activation of Visudyne 15 minutes after the start of the infusion. For this, a diode laser generating nonthermal red light (wavelength 689 nanometre) is delivered via a slit lamp mounted fibre optic device and a suitable contact lens. At the recommended light intensity of 600 mW/cm2 it takes 83 seconds to deliver the required light dose of 50 J/cm2.
The Visudyne and Photodynamic therapy is performed once at the baseline visit.
Intervention code [1] 2210 0
Treatment: Drugs
Comparator / control treatment
Data from the Randomized Controlled Trial (RCT) (Mariner/Anchor) as the control.
Control group
Historical

Outcomes
Primary outcome [1] 3490 0
To evaluate the mean change from baseline in best corrected visual acuity (BCVA) in patients treated with combination therapy using Visudyne and Lucentis.
The BCVA of subjects will be measured consistent with the standard procedure developed for the Early Treatment Diabetic Retinopathy Study (ETDRS). The following equipment is used: a set of three charts which are modified ETDRS charts 1 and 2, and a retro-illuminated box .
A distance of 4 metres is required between the subject's eyes and the visual acuity chart.
Subjective refraction is performed to prior to the BCVA test
Timepoint [1] 3490 0
Baseline, then every six weeks for 12 months. A total of 9 time points.
Secondary outcome [1] 262538 0
Mean change from baseline in retinal thickness. This is assess prior to the Ocular Coherence Tomography test (OCT).
This is a computerized imaging technique that uses laser light to make a 3-D image of the retina. It is a simple test to perform. Usually the pupil must be dilated and then the patient sits in front of a special type of camera and pictures are taken of the structures inside the eye. It is painless and not uncomfortable. For cooperative patients the test can be completed in a few minutes.
Timepoint [1] 262538 0
Baseline, then every six weeks for 12 months. A total of 9 time points.
Secondary outcome [2] 262539 0
Qualitative change in degree of sub/intra-retinal fluid
Timepoint [2] 262539 0
Baseline, then every six weeks for 12 months. A total of 9 time points.
Secondary outcome [3] 262540 0
Mean number of Lucentis injections over 12 months.
Timepoint [3] 262540 0
Baseline, then every six weeks for 12 months. A total of 9 time points.

Eligibility
Key inclusion criteria
Age>50 years,
Males and females,
Patients presenting with subretinal neovascular membrane secondary to AMD,
All lesion types (predominantly classic, minimally classic, occult),
Lesions of < 5,400 mm in greatest linear dimension,
Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 in the study eye,
Eligible for treatment with Visudyne in the study eye according to the Visudyne prescribing information.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Porphyria or a known hypersensitivity to verteporfin or to any of the excipients,
Patients with a history of liver impairment or biliary obstruction will be excluded
Retreatment in therapy assoc. severe vision loss; unstable heart disease, uncontrolled hypertension; pregnancy, lactation, children
Prior treatment in the study eye with Visudyne, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy,
History of submacular surgery or other surgical intervention for Age Macular Degeneration (AMD) in the study eye, glaucoma filtration surgery, corneal transplant surgery,
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
Patients with angioid streaks or precursors of choroidal neovascularisation (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia,
Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.),
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma medication),
Aphakia with absence of the posterior capsule in the study eye,
Active intraocular inflammation (grade trace or above) in the study eye,
Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye,
Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
Presence of a retinal pigment epithelial tear involving the macula in the study eye, Subfoveal fibrosis or significant atrophy in the study eye
Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
Known sensitivity to study drug(s) or class of study drug(s)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
It is a non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Twenty patients with subfoveal neovascular AMD regardless of lesion type (predominantly classic, minimally classic and occult CNV) who have not previously been treated with laser photocoagulation, Visudyne or an anti-VEGF therapy will be
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 301 0
5000

Funding & Sponsors
Funding source category [1] 2737 0
Commercial sector/Industry
Name [1] 2737 0
Novartis
Country [1] 2737 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce
Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 2472 0
None
Name [1] 2472 0
Address [1] 2472 0
Country [1] 2472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4653 0
Research Ethics Committee, Royal Adelaide Hsp
Ethics committee address [1] 4653 0
Research Ethics Committee (REC)
Lev 3 Insitute of Medical and Veterinary Science (IMVS)
Royal Adelaide Hospital
North Tce South Australia 5000
Ethics committee country [1] 4653 0
Australia
Date submitted for ethics approval [1] 4653 0
Approval date [1] 4653 0
03/09/2007
Ethics approval number [1] 4653 0
CBPQ95211UOI

Summary
Brief summary
Our hypothesis is that with the combination of Photodynamic Therapy (PDT) and Ranibizumab patient would need fewer intravitreal injections. This would be of benefit to the patients in terms of reduced exposure to Ranibizumab as well as importantly a reduced risk of adverse events from the intravitreal injection procedure. In addition, there would be a benefit to the community with a in terms of reduced cost.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28132 0
Address 28132 0
Country 28132 0
Phone 28132 0
Fax 28132 0
Email 28132 0
Contact person for public queries
Name 11289 0
Kylie Dansie
Address 11289 0
Ophthalmology Network
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 11289 0
Australia
Phone 11289 0
+61 8 8222 2729
Fax 11289 0
+61 8 8222 2747
Email 11289 0
[email protected]
Contact person for scientific queries
Name 2217 0
Dr Grant L Raymond
Address 2217 0
Ophthalmology Network
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 2217 0
Australia
Phone 2217 0
+61 8 8222 2729
Fax 2217 0
+61 8 8222 2741
Email 2217 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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