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

May 14, 2014 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

720

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

March 24, 2003

First Submitted That Met QC Criteria

March 25, 2003

First Posted (Estimate)

March 26, 2003

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF2598g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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