Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
Status unconfirmed · Phase 1
Conditions studied: Venous Retinal Branch Occlusion, Central Retinal Vein Occlusion, Retinal Vein Occlusion, Depression
In brief
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.
Key facts
- Study ID
- NCT01011374
- Run by
- Retina Associates of Cleveland, Inc
- People needed
- 45
- Starts
- 2009-11-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2011-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Retina Associates of Cleveland — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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