Intravitreal Anti-VEGF in Exudative AMD With Epiretinal M... | NCT01846351

Studies
Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes

NCT01846351

Sponsor

New England Retina Associates

Status

Completed

Last Update Posted

May 3, 2013Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Epiretinal Membrane
Age Related Macular Degeneration

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

May 1, 2013

First Submission Date that Met QC Criteria

May 1, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2013

Last Update Posted Date

May 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter E. Liggett, Principal Investigator, New England Retina AssociatesPrincipal Investigator

Lead Sponsor

New England Retina AssociatesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity	Evaluate the best visual acuity during the follow up.	12 months
Central macular thickness	Evaluation of the retinal thickness changes with anti-VEGF treatment	12 months
Fluorescein angiogram	Evaluation of changes in lesion size during follow-up.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Significant epiretinal membrane
Anti-VEGF treatment for age-related macular degeneration

Exclusion Criteria:

Uveitis
Macular disorders
Diabetic retinopathy
Vascular occlusions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

58 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

age-related macular degeneration

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nauman A Chaudhry, MD	New England Retina Associates	Principal Investigator
Peter E Liggett, MD	New England Retina Associates	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D012162	Retinal Degeneration
D015862	Choroid Diseases

Browse Leaves

Not provided

Browse Branches

Not provided