Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Retina Associates of Cleveland, Inc
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam

• Age 18 years or over

• Central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250 microns

• Visual acuity ranging from 20/8000 to 20/40

• Media clarity and patient cooperation sufficient to allow adequate testing utilizing OCT and FA

• No previous treatment that might compromise or confound assessment of the study outcomes

• Ability to speak and read English

Exclusion Criteria:

• Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements

• Concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise

• History of grid/focal laser in the study eye

• History of vitreal surgery

• Previous treatment with triamcinolone acetonide in either eye

• Previous use of bevacizumab, pegaptanib, or ranibizumab in either eye

• Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders

• History of cerebrovascular accident within 1 year prior to Day 0

• Inability to comply with study or follow-up procedures

• Any cognitive defect as a result of mental disease, previous injury, or disease process that may interfere with interpretation of study results

• Visual acuity better than 20/40

• Pregnancy (positive pregnancy test) or lactation

• Inadequate contraception in premenopausal women