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

NCT01015495 | Withdrawn Phase 1

• 1 other identifier: fvf 3763s
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Angioid Streaks

Keywords

angioid streaks; CNV; intra vitreal ranibizumab

Outcome Measures

Primary Outcomes (1)

• 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)

  Month 12

Secondary Outcomes (1)

• 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

  Month 6 and 12

Study Arms (1)

ranibizumab

EXPERIMENTAL

Drug: ranibizumab

Interventions

ranibizumab DRUG

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

Also known as: Lucentis

ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Genentech, Inc.: collaborator

Related Links

• UIC-Ophthalmology home page

MeSH Terms

Conditions

Angioid Streaks

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jennifer I Lim, MD

  UIC Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 2, 2012

Record last verified: 2012-06