Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00061594




Registration number
NCT00061594
Ethics application status
Date submitted
29/05/2003
Date registered
30/05/2003
Date last updated
19/03/2014

Titles & IDs
Public title
A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration
Scientific title
A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
Secondary ID [1] 0 0
FVF2587g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rhuFab V2 (ranibizumab)

Treatment: Drugs: rhuFab V2 (ranibizumab)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Signed informed consent

- Age >=50 years

- Eligibility for treatment with PDT using verteporfin in the study eye according to the
Visudyne product labeling

- Future treatment with PDT using verteporfin anticipated or expected in the study eye

- Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to
age-related macular degeneration (AMD) in the study eye

- A classic CNV component (well-demarcated hyperfluorescence boundaries in the early
phase of the fluorescein angiogram) that is >=50% of the total lesion size

- Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)

- Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study
(ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary
thermotherapy (TTT) in the study eye

- Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0

- Previous participation in a clinical trial (for either eye) involving anti angiogenic
drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or
device implantation) in the study eye

- Previous subfoveal focal laser photocoagulation in the study eye

- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
preceding Day 0

- History of vitrectomy surgery in the study eye

- History of submacular surgery or other surgical intervention for AMD in the study eye

- Previous participation in any studies of investigational drugs within 1 month
preceding Day 0 (excluding vitamins and minerals)

- Subretinal hemorrhage in the study eye that involves the center of the fovea, if the
size of the hemorrhage is either >=50% of the total lesion area or >=1 disc area (DA)
in size

- Subfoveal fibrosis or atrophy in the study eye

- CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
pathologic myopia

- Retinal pigment epithelial tear involving the macula in the study eye

- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic
retinopathy) that, in the opinion of the Investigator could either: (1) Require
medical or surgical intervention during the 24-month study period to prevent or treat
visual loss that might result from that condition, or (2) If allowed to progress
untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of
best corrected visual acuity over the 24-month study period

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

- Current vitreous hemorrhage in the study eye

- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the
study eye

- History of idiopathic or autoimmune-associated uveitis in either eye

- Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

- Aphakia or absence of the posterior capsule in the study eye

- Spherical equivalent of the refractive error in the study eye demonstrating more than
-8 diopters of myopia

- Intraocular surgery (including cataract surgery) in the study eye within 2 months
preceding Day 0

- Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg
despite treatment with anti-glaucoma medication)

- History of glaucoma filtering surgery in the study eye

- History of corneal transplant in the study eye

- Premenopausal women not using adequate contraception

- History of other 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 or that might affect interpretation
of the results of the study or render the subject at high risk for treatment
complications

- Current treatment for active systemic infection

- History of allergy to fluorescein, not amenable to treatment

- Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality
to be analyzed and graded by the central reading center

- 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
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
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Melbourne, Department of Ophthalmology - East Melbourne
Recruitment hospital [2] 0 0
Marsden Eye Research Pty Ltd - Parramatta
Recruitment hospital [3] 0 0
Save Sight Institute - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
VIC-3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
NSW 2150 - Parramatta
Recruitment postcode(s) [3] 0 0
NSW-2000 - Sydney
Recruitment postcode(s) [4] 0 0
NSW-2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Praha 10
Country [28] 0 0
France
State/province [28] 0 0
Creteil Cedex
Country [29] 0 0
France
State/province [29] 0 0
Marseille
Country [30] 0 0
France
State/province [30] 0 0
Paris Cedex 10
Country [31] 0 0
Germany
State/province [31] 0 0
Bonn
Country [32] 0 0
Germany
State/province [32] 0 0
Koln
Country [33] 0 0
Germany
State/province [33] 0 0
Leipzig
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase III, multicenter, randomized, double-masked, active treatment-controlled
study of intravitreally administered ranibizumab compared with verteporfin (Visudyne)
photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00061594
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/NCT00061594