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

Depression Clinical Trial

Official title:

Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01011374
• Other study ID #: FVF4638s
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 9, 2009
• Last updated: March 16, 2011
• Start date: November 2009
• Est. completion date: November 2013

Study information

• Verified date: March 2011
• Source: Retina Associates of Cleveland, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Depression
• Retinal Vein Occlusion
• Venous Retinal Branch Occlusion

Intervention

Drug:
• ranibizumab (Lucentis)
0.5 mg, administered intravitreally every 4 weeks

Locations

Country	Name	City	State
United States	Retina Associates of Cleveland	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Retina Associates of Cleveland, Inc	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.		24 weeks	No
Secondary	Secondary outcome measures are change in macular edema measured by OCT and estimated by central retinal thickening and correlations between change in visual acuity, depression, and retinal findings such as neovascularization, rubeosis, and perfusion.		24 weeks	No