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

This study has been withdrawn prior to enrollment.
(Not enough patients within the time frame to allow for a meaningful study.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Jennifer I. Lim, University of Illinois
ClinicalTrials.gov Identifier:
NCT01015495
First received: November 17, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Angioid Streaks
Drug: ranibizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2009
Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lucentis

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015495

Sponsors and Collaborators
University of Illinois at Chicago
Genentech, Inc.
Investigators
Principal Investigator: Jennifer I Lim, MD UIC Eye and Ear Infirmary
  More Information

Additional Information:
No publications provided

Responsible Party: Jennifer I. Lim, Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences, University of Illinois
ClinicalTrials.gov Identifier: NCT01015495     History of Changes
Other Study ID Numbers: fvf 3763s
Study First Received: November 17, 2009
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
angioid streaks
CNV
intra vitreal ranibizumab

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Angioid Streaks
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014