NCT01011374

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 18, 2011

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

November 9, 2009

Last Update Submit

March 16, 2011

Conditions

Venous Retinal Branch OcclusionCentral Retinal Vein OcclusionRetinal Vein OcclusionDepression

Keywords

Retinal vein occlusionRanibizumabLucentisDepression

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.

    24 weeks

Secondary Outcomes (1)

  • 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

Interventions

ranibizumab (Lucentis)DRUG

0.5 mg, administered intravitreally every 4 weeks

Also known as: Lucentis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Associates of Cleveland

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Retinal Vein OcclusionDepression

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lawrence J Singerman, MD

    Retina Associates of Cleveland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

March 18, 2011

Record last verified: 2011-03

Locations

US(1)