Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks

June 28, 2012 updated by: Jennifer I. Lim, University of Illinois at Chicago

Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks

The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Angioid streaks
  • Subfoveal CNV of recent onset with the following characteristics
  • Absence of subfoveal fibrosis
  • Fibrosis less than 25% of the lesion
  • Presence of blood, subretinal fluid, and/or lipid
  • New onset symptoms within 12 weeks
  • Visual acuity 20/40 to 20/800 on an ETDRS chart

Exclusion Criteria:

  • Prior treatment of subfoveal CNV in the study eye
  • Age-related macular degeneration
  • Uncontrolled glaucoma
  • High myopia (> -10.00 D spherical equivalent)
  • Prior retinal detachment
  • Media opacity preventing adequate view of the retina
  • Planned cataract surgery in the next 3 months
  • Current chemotherapy for cancer
  • Immunocompromised state
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • History of any previous treatment for angioid streaks

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ranibizumab
Drug: ranibizumab
0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12
Time Frame: Month 6 and 12
Month 6 and 12

Collaborators and Investigators

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

Sponsor

University of Illinois at Chicago

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Jennifer I Lim, MD, UIC Eye and Ear Infirmary

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.

Helpful Links

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

December 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (ESTIMATE)

November 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fvf 3763s

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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