Epiretinal MembraneNCT01846351
Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes
An observational study of Epiretinal Membrane and Age Related Macular Degeneration, run by New England Retina Associates.
Trial summary
Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD. Read more about this study
- Who is it for?
- Ages 58 to 90 years
- Conditions the study is for
- Epiretinal Membrane, Age Related Macular Degeneration
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: age-related macular degeneration
Who may be able to join
- Significant epiretinal membrane
- Anti-VEGF treatment for age-related macular degeneration
Who cannot join
- Uveitis
- Macular disorders
- Diabetic retinopathy
- Vascular occlusions
About this study
Official title: Visual and Anatomic Outcomes of Intravitreal Anti-VEGF Therapy for Exudative Age-related Macular Degeneration With Concurrent Significant Epiretinal Membrane.
Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.
Read the 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.
- Keywords
- choroidal neovascularization, epiretinal membrane, anti-VEGF
- Medical subject headings
- Epiretinal Membrane, Macular Degeneration, Choroidal Neovascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Evaluate the best visual acuity during the follow up.
Measured: 12 months
Central macular thickness
Evaluation of the retinal thickness changes with anti-VEGF treatment
Measured: 12 months
Fluorescein angiogram
Evaluation of changes in lesion size during follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJul 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- New England Retina Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter E. Liggett, New England Retina Associates
- Investigators
- Nauman A Chaudhry, MD, Principal investigator, New England Retina AssociatesPeter E Liggett, MD, Study chair, New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846351
- Sponsor's protocol ID
- NAC270608
- Status last verified
- May 2013
- First submitted
- 1 May 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Anatomic Outcomes of Intravitreal Anti-VEGF Therapy for Exudative Age-related Macular Degeneration With Concurrent Significant Epiretinal Membrane.
- ClinicalTrials.gov ID
- NCT01846351
- Acronym / sponsor ID
- NAC270608
- Keywords
- choroidal neovascularization, epiretinal membrane, anti-VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- New England Retina AssociatesUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 58 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age-related macular degeneration
Key inclusion criteria (2 listed)
- Significant epiretinal membrane
- Anti-VEGF treatment for age-related macular degeneration
Key exclusion criteria (4 listed)
- Uveitis
- Macular disorders
- Diabetic retinopathy
- Vascular occlusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best corrected visual acuity
Time frame: 12 months
Evaluate the best visual acuity during the follow up.
Central macular thickness
Time frame: 12 months
Evaluation of the retinal thickness changes with anti-VEGF treatment
Fluorescein angiogram
Time frame: 12 months
Evaluation of changes in lesion size during follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
Related trials for Epiretinal Membrane
Recruiting
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Epiretinal Membrane
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
Recruiting
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Epiretinal Membrane, Dry Age Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nauman A Chaudhry, MD principal investigator
New England Retina Associates
Peter E Liggett, MD study chair
New England Retina Associates
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membrane and Age Related Macular Degeneration, run by New England Retina Associates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.