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

Retina Associates of Cleveland, Inc

Status and phase

Unknown

Phase 1

Conditions

Central Retinal Vein Occlusion

Retinal Vein Occlusion

Depression

Venous Retinal Branch Occlusion

Treatments

Drug: ranibizumab (Lucentis)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01011374

FVF4638s

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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