A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056836
• Other study ID #: FVF2598g
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2003
• Last updated: May 14, 2014
• Start date: March 2003
• Est. completion date: December 2005

Study information

• Verified date: May 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age >=50 years

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

• Lesions with occult CNV or with some classic CNV component are permissible. However, if classic CNV (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) is present, the area of classic CNV must be <50% of the total lesion size.

• The total area of CNV (including both classic and occult components) encompassed within the lesion must be >=50% of the total lesion area.

• The total lesion area must be <=12 disc areas (DA) in size.

• 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

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 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• rhuFab V2 (ranibizumab)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

References & Publications (2)

Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. — View Citation

Suñer IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs — View Citation