Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
This study is ongoing, but not recruiting participants.
Sponsor:
Retina Associates of Cleveland, Inc
Collaborator:
Genentech
Information provided by:
Retina Associates of Cleveland, Inc
ClinicalTrials.gov Identifier:
NCT01011374
First received: November 9, 2009
Last updated: March 16, 2011
Last verified: March 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Retinal Branch Occlusion Central Retinal Vein Occlusion Retinal Vein Occlusion Depression |
Drug: ranibizumab (Lucentis) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion |
Resource links provided by NLM:
Further study details as provided by Retina Associates of Cleveland, Inc:
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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: ranibizumab (Lucentis)
0.5 mg, administered intravitreally every 4 weeks
Other Name: Lucentis
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011374
Locations
| United States, Ohio | |
| Retina Associates of Cleveland | |
| Cleveland, Ohio, United States, 44122 | |
Sponsors and Collaborators
Retina Associates of Cleveland, Inc
Genentech
Investigators
| Principal Investigator: | Lawrence J Singerman, MD | Retina Associates of Cleveland |
More Information
No publications provided
| Responsible Party: | Lawrence J. Singerman, MD, Retina Associates of Cleveland |
| ClinicalTrials.gov Identifier: | NCT01011374 History of Changes |
| Other Study ID Numbers: | FVF4638s |
| Study First Received: | November 9, 2009 |
| Last Updated: | March 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Retina Associates of Cleveland, Inc:
|
Retinal vein occlusion Ranibizumab Lucentis Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Retinal Vein Occlusion Behavioral Symptoms Mood Disorders Mental Disorders Retinal Diseases |
Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013