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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01846351
Other study ID # NAC270608
Secondary ID
Status Completed
Phase N/A
First received May 1, 2013
Last updated May 1, 2013
Start date July 2006
Est. completion date February 2010

Study information

Verified date May 2013
Source New England Retina Associates
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.


Description:

Gass in 1987 described three cases of epiretinal membrane (ERM) associated with wet macular degeneration. Since then we have seen that is not rare to find the coexistence of these entities. An ERM may produce intrinsic disorganization of the outer retina leading to persistent increased macular thickness and/or edema. This persistent edema may affect the effectiveness in the treatment of exudative age-related macular degeneration (eAMD). Therefore, this study was designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 58 Years to 90 Years
Eligibility Inclusion Criteria:

- Significant epiretinal membrane

- Anti-VEGF treatment for age-related macular degeneration

Exclusion Criteria:

- Uveitis

- Macular disorders

- Diabetic retinopathy

- Vascular occlusions

Study Design

Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
New England Retina Associates

Outcome

Type Measure Description Time frame Safety issue
Primary Best corrected visual acuity Evaluate the best visual acuity during the follow up. 12 months No
Primary Central macular thickness Evaluation of the retinal thickness changes with anti-VEGF treatment 12 months No
Primary Fluorescein angiogram Evaluation of changes in lesion size during follow-up. 12 months No
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