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NCT05844982RECRUITINGIRB Ready

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

(AL)

Sponsored by Jaeb Center for Health Research

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 600 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.

Who Can Participate

Inclusion Criteria

Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy
Absence of unrelated cause of visual loss
Baseline visual acuity โ‰ฅ 34 letters (20/200 Snellen equivalent or better)
Posterior tumor margin \>0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)
Posterior tumor margin \>0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc)
Calculated total dose to center of the macula โ‰ฅ30 Gy Key

Exclusion Criteria

Opaque media
Inability to undergo fluorescein angiography
Less than 18 years of age
Prior vitrectomy
Intraocular pressure (IOP) โ‰ฅ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline
IOP โ‰ฅ 25 mmHg at randomization or increase in IOP โ‰ฅ 8 mmHg from baseline to randomization (following steroid challenge

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

600 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Jaeb Center for Health Research

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
RECRUITING

Manchester

Connecticut

Location available
View Manchester location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Indianapolis

Indiana

Location available
View Indianapolis location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

Grand Rapids

Michigan

Location available
View Grand Rapids location page
RECRUITING

Royal Oak

Michigan

Location available
View Royal Oak location page

๐Ÿ“ And 11 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Radiation Retinopathy Treatment in Palo Alto?

Join others in California exploring innovative treatment options through clinical research

Radiation Retinopathy Treatment Options in Palo Alto, California

If you're searching for Radiation Retinopathy treatment in Palo Alto, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Palo Alto, Tampa, Chicago and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Radiation Retinopathy. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 600 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Radiation Retinopathy?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Radiation Retinopathy

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Radiation Retinopathy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05844982. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.