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

NCT ID: NCT01011374

Last Updated: 2011-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-11-30

Brief 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.

Conditions

Venous Retinal Branch Occlusion; Central Retinal Vein Occlusion; Retinal Vein Occlusion; Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ranibizumab (Lucentis)

0.5 mg, administered intravitreally every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Retina Associates of Cleveland, Inc

OTHER

Sponsor Role: lead

Responsible Party

Retina Associates of Cleveland

Principal Investigators

Lawrence J Singerman, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Associates of Cleveland

Locations

Retina Associates of Cleveland

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

FVF4638s

Identifier Type: -

Identifier Source: org_study_id