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WithdrawnNCT01015495Updated Jul 2, 2012

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

A Phase 1/2 interventional study of ranibizumab in Angioid Streaks, sponsored by University of Illinois at Chicago. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-02.

Sponsored by University of Illinois at Chicago · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Not enough patients within the time frame to allow for a meaningful study.
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Angioid Streaks

Keywords

  • angioid streaks
  • CNV
  • intra vitreal ranibizumab
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In context

Choroidal Neovascularization

188 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.

Browse Choroidal Neovascularization studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    ranibizumab

    Drug: ranibizumab

Interventions

  • Drugranibizumab

    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

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What researchers measure

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)

    Time frame: 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

    Time frame: Month 6 and 12

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01015495
Lead sponsor
University of Illinois at Chicago
Collaborators
Genentech, Inc.
Responsible party
Jennifer I. Lim (Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago) — Principal investigator
First posted
Nov 18, 2009
Start date
Dec 2009
Primary completion
Dec 2010 (estimated)
Completion
Jan 2011
Last update
Jul 2, 2012

Study contacts

Jennifer I Lim, MD
principal investigator · UIC Eye and Ear Infirmary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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