Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

NCT00561834 | Completed Phase 1 Results

• 2 other identifiers: 07-0446genentech FVF4256s
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy

Keywords

non-arteritic ischemic optic neuropathy; ranibizumab; naion

Outcome Measures

Primary Outcomes (1)

• Change in Visual Acuity

  The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.

  Baseline and 6 months

Study Arms (1)

Ranibizumab

EXPERIMENTAL

To determine the mean change in best corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study testing system at 6 months in NAION patients treated as needed (PRN) with ranibizumab.

Drug: ranibizumab

Interventions

ranibizumab DRUG

All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.

Ranibizumab

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provide written informed consent
• years of age or older
• new onset, within 14 days, of ischemia and vision loss
• Best Corrected Visual Acuity (BCVA) 20/40 or worse

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Rocky Mountain Lions Eye Institute

Aurora, Colorado, 80045-0510, United States

Location

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Naresh Mandava, M.D.
• Organization: Rocky Mountain Lions Eye Institute, Dept. of Ophthalmology

Naresh.mandava@ucdenver.edu

720-848-2500

Study Officials

• Naresh Mandava, MD

  Rocky Mountain Lions Eye Institute, University of Colorado Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 30, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)