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

Angioid Streaks Clinical Trial

Official title:

Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01015495
• Other study ID #: fvf 3763s
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: November 17, 2009
• Last updated: June 28, 2012
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: University of Illinois at Chicago
• 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 ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioid Streaks
• Choroidal Neovascularization
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   UIC-Ophthalmology home page