Phase 1
N=2
Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy
Nonarteritic Anterior Ischemic Optic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00561834 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Change in Visual Acuity — 4; 3 lines change in Snellen chart
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ranibizumab (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Acuity |
4; 3 | — |
Summary
The purpose of this study is to explore the safety and efficacy of ranibizumab to treat non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.
Eligibility Criteria
Inclusion Criteria
- provide written informed consent
- 21 years of age or older
- new onset, within 14 days, of ischemia and vision loss
- Best Corrected Visual Acuity (BCVA) 20/40 or worse
Exclusion Criteria
- pregnancy or lactation
- proliferative diabetic retinopathy,
- diabetic macular edema,
- uveitis,
- history of ocular trauma,
- severe glaucoma,
- age-related macular degeneration.
- prior or concomitant treatment of oral steroids within 30 days,
- participation in any studies of investigational drugs within 30 days,
- participation in a ranibizumab clinical trial or,
- prior treatment intravitreally or intravenously of Avastin or steroids.
Data sourced from ClinicalTrials.gov (NCT00561834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.