- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01011374
Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
March 16, 2011 updated by: Retina Associates of Cleveland, Inc
Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44122
- Retina Associates of Cleveland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lawrence J Singerman, MD, Retina Associates of Cleveland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
November 1, 2013
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Estimate)
March 18, 2011
Last Update Submitted That Met QC Criteria
March 16, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Depression
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- FVF4638s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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