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Phase 1 N=2 Treatment

Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

Nonarteritic Anterior Ischemic Optic Neuropathy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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