Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
Primary Purpose
Venous Retinal Branch Occlusion, Central Retinal Vein Occlusion, Retinal Vein Occlusion
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab (Lucentis)
Sponsored by
About this trial
This is an interventional treatment trial for Venous Retinal Branch Occlusion focused on measuring Retinal vein occlusion, Ranibizumab, Lucentis, Depression
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
Sites / Locations
- Retina Associates of Cleveland
Outcomes
Primary Outcome Measures
The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01011374
First Posted
November 9, 2009
Last Updated
March 16, 2011
Sponsor
Retina Associates of Cleveland, Inc
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01011374
Brief Title
Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
Official Title
Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Retina Associates of Cleveland, Inc
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Retinal Branch Occlusion, Central Retinal Vein Occlusion, Retinal Vein Occlusion, Depression
Keywords
Retinal vein occlusion, Ranibizumab, Lucentis, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ranibizumab (Lucentis)
Other Intervention Name(s)
Lucentis
Intervention Description
0.5 mg, administered intravitreally every 4 weeks
Primary Outcome Measure Information:
Title
The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence J Singerman, MD
Organizational Affiliation
Retina Associates of Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
12. IPD Sharing Statement
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Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
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