What side effects are associated with this type of intervention?

Vitrectomy, a common treatment for Macular Pucker, involves the surgical removal of the epiretinal membrane to improve visual acuity and reduce metamorphopsia. Known side effects of this procedure include cataract formation, retinal detachment, intraocular infections, increased intraocular pressure, and macular edema. It is crucial to discuss these potential complications with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The primary FDA-approved treatment for Macular Pucker is vitrectomy, a surgical procedure that involves the removal of the epiretinal membrane to improve visual acuity and reduce metamorphopsia. This procedure is commonly recommended when patients experience significant visual impairment. There are no specific FDA-approved drugs for Macular Pucker; the focus remains on surgical intervention to address the condition.

What other types of research exist?

As of 2024, promising novel alternatives to vitrectomy for macular pucker patients include pharmacologic treatments such as intravitreal injections of anti-VEGF agents and corticosteroids, which aim to reduce inflammation and fibrosis. Additionally, advancements in laser therapy and the development of enzyme-based treatments to dissolve the epiretinal membrane are being explored. These alternatives are still under investigation but show potential in providing non-surgical options for improving visual acuity and reducing metamorphopsia.

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Procedure

Immediate vs. Deferred Surgery for Macular Pucker (Protocol AM Trial)

N/A

Recruiting

Research Sponsored by Jaeb Center for Health Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ERM is not secondary to another condition

Epiretinal membrane involving or altering the central 3 mm of the macula on OCT

Must not have

Prior intraocular surgery (except uncomplicated cataract extraction)

History of retinal vascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the best time for eye surgery to remove a membrane that can cause vision problems. It focuses on patients with noticeable eye changes but still good vision. The goal is to see if surgery leads to better vision outcomes and to understand how symptoms like visual distortion affect patients.

Who is the study for?

This trial is for people with a condition called Macular Pucker, who have vision between 20/25 and 20/40. They should experience visual loss or distortion due to an epiretinal membrane (ERM) affecting the central part of the retina. Surgery shouldn't be urgently needed, and they mustn't have other health issues that make surgery risky.

What is being tested?

The study compares immediate vs. deferred vitrectomy surgery in patients with symptomatic ERM to determine which timing results in better vision outcomes. It also aims to identify factors predicting success when surgery is performed and progression if it's delayed.

What are the potential side effects?

While specific side effects are not listed here, vitrectomy procedures can generally lead to complications like infection, bleeding inside the eye, retinal detachment, cataracts, or changes in eye pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eye condition is not caused by another health issue.

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I have a membrane affecting the central part of my retina.

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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had eye surgery before, but only for cataracts and without complications.

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I have had diseases affecting the blood vessels in my eyes.

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I have a condition where the gel in my eye is pulling on the central part of my retina.

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I have had laser or cryosurgery on my retina within the last month.

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My diabetic eye condition is moderate to severe.

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I have an untreated tear or detachment in my retina.

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I have had cataract surgery in the last 3 months.

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I have a type of macular hole in my eye.

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I have a macular hole in my eye.

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I have been diagnosed with central serous chorioretinopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in visual acuity letter score from baseline to 36 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Deferred VitrectomyExperimental Treatment1 Intervention

Group II: Immediate VitrectomyActive Control1 Intervention

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Vitrectomy is a surgical procedure that involves the removal of the vitreous gel from the eye, followed by the peeling of the epiretinal membrane (ERM) from the surface of the retina. This procedure helps to relieve the traction on the retina caused by the ERM, which can improve visual acuity and reduce symptoms such as metamorphopsia (visual distortion). For Macular Pucker patients, this is significant because it can restore the normal architecture of the macula, leading to better visual outcomes and an improved quality of life.