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Monoclonal Antibodies

Intravitreal faricimab for Visual Impairment (AL Trial)

Phase 3

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

Posterior tumor margin >0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)

Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline at 3 years

Awards & highlights

AL Trial Summary

This trial will compare the effects of two different treatments (intravitreal faricimab or fluocinolone acetonide implant) with doing nothing (observation) on the long-term vision

Who is the study for?

This trial is for people with primary uveal melanoma treated with plaque brachytherapy, who have a baseline vision of at least 20/200 Snellen equivalent and no other causes for visual loss. The tumor must not be under the center of the fovea or touching the optic disc edge, and the macula should receive a dose of ≥30 Gy.Check my eligibility

What is being tested?

The study compares two treatments to prevent vision loss from radiation retinopathy after choroidal melanoma treatment: injections of Faricimab into the eye (intravitreal) versus Fluocinolone Acetonide implants in the eye, against just watching without treatment.See study design

What are the potential side effects?

Possible side effects include eye discomfort or pain, increased intraocular pressure, cataract formation, bleeding inside the eye (hemorrhage), infection risk post-injection or implantation, and potential allergic reactions.

AL Trial Eligibility Criteria

Inclusion Criteria

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

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My eye tumor is not located under the central part of my vision.

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I am receiving initial treatment with a specific radiation therapy for melanoma in my eye, excluding the iris.

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My vision loss is not due to any unrelated condition.

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The center of my retina has been exposed to a high level of radiation.

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It seems like there might be a mistake in your request. If you could provide more context or clarify, I'd be happy to assist you with summarizing the criteria.

AL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline at 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline at 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline at 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in visual acuity from baseline

Loss of 15 or more letters of visual acuity from baseline

AL Trial Design

3Treatment groups

Active Control

Group I: Intravitreal faricimabActive Control1 Intervention

Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.

Group II: Fluocinolone Acetonide Intravitreal ImplantsActive Control1 Intervention

Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle

Group III: ObservationActive Control1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,401,557 Total Patients Enrolled

2 Trials studying Visual Impairment

105 Patients Enrolled for Visual Impairment

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

567,543 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different facilities is this research study currently being administered?

"Six medical facilities are currently conducting this study. Notable sites include Retina-Vitreous Consultants, Inc. in Monroeville, Midwest Eye Institute in Indianapolis, and Retina Consultants of Carolina, PA in Greenville. Additionally, there are six other locations participating in the trial."

Answered by AI

Has the FDA granted approval for the use of intravitreal faricimab?

"In consideration of this being a Phase 3 trial, which indicates the availability of data supporting both efficacy and safety from multiple rounds of testing, our team at Power rates the safety of Intravitreal faricimab as a 3."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"To conduct this research, a total of 600 individuals who meet the eligibility criteria are needed. The trial will be conducted by Alimera Sciences, with participation from various sites including Retina-Vitreous Consultants, Inc. located in Monroeville, Pennsylvania and Midwest Eye Institute situated in Indianapolis, Indiana."

Answered by AI

Are researchers actively seeking participants for this study at the moment?

"Indeed, the information available on clinicaltrials.gov indicates that this particular trial is actively seeking eligible individuals. The trial was initially posted on November 21st, 2023 and had its most recent update on December 21st, 2023. A total of six medical sites are involved in recruiting approximately 600 patients for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

2023. "Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844982.