NCT01080898

Brief Summary

Determination of the sensitivity and specificity of different combinations of imaging techniques (spectral domain optical coherence tomography, fundus photography and fluorescein angiography) used for the diagnosis of choroidal neovessels complicating age -related macular degeneration. This information will help to determine the choice of the most suitable combination for the above diagnosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Status
completed

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

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 23, 2012

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

January 28, 2010

Last Update Submit

July 20, 2012

Conditions

Age-Related Macular DegenerationChoroidal Vessels; Anastomosis

Keywords

Age - Related Macular DegenerationOptical Coherence TomographyChoroidal neovascularizationFLORESCEIN AngiographyFundus photographs

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photos in the diagnosis of choroidal neovessels in age- related macular degeneration.

    all outcome the day of inclusion

Secondary Outcomes (6)

  • Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography in the diagnosis of choroidal neovessels in age - related macular degeneration.

    all the outcome the day of inclusion

  • Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography, and of fluorescein angiography combined with fundus color photography.

    all outcome the day of inclusion

  • Rate of unusable images for each technique

    all outcome the day of inclusion

  • Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels

    all outcome the day of inclusion

  • Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels.

    all outcome the day of inclusion

  • +1 more secondary outcomes

Study Arms (1)

DMLA patients

patients \> 50 years with suspicion of choroidal neo-vessels complicating age related macular degeneration (DMLA)

Other: tests

Interventions

testsOTHER

color photographs, FLUORESCEIN angiography and OCT

DMLA patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients \> 50 years with suspicion of choroidal neo-vessels complicating age relatid macular degeneration (DMLA)

You may qualify if:

  • Age\> 50 years
  • First visit for suspicion of choroidal neo-vessels complicating age related macular degeneration
  • Fundus color photographs , FLUORESCEIN angiography and OCT prescription

You may not qualify if:

  • Age \< 50 years
  • Diabetes
  • Central vein occlusion Macular hole Epi-retinal membrane Retinal detachment Macular hemorrhage more than the 1/3 of the lesion
  • History of macular laser, PDT or intra-vitreal injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ramin TADAYONI, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

March 4, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 23, 2012

Record last verified: 2011-04