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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Retina Associates of Cleveland, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech, Inc.
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
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
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Mental Disorders
Mood Disorders
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on October 23, 2014