272 Participants NeededMy employer runs this trial

FWY003 for Macular Degeneration

Recruiting at 52 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FWY003 for individuals with geographic atrophy (GA) due to age-related macular degeneration (AMD), a condition that affects the eyes and can lead to vision loss. Researchers aim to understand how different doses of FWY003 impact the condition. The trial includes different groups; some participants receive varying doses of the treatment, while others receive a placebo (inactive substance). This trial may suit individuals diagnosed with GA related to AMD in at least one eye who have not had recent eye surgery or certain other eye conditions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that FWY003 has undergone testing in earlier human trials. Research indicates it was generally well-tolerated, with most participants experiencing no problems. Importantly, no serious side effects directly linked to the treatment were reported. This suggests that FWY003 may be safe for use. However, like any new treatment, unknown risks might still exist. Researchers closely monitor participants during the trials to ensure their safety.12345

Why do researchers think this study treatment might be promising for macular degeneration?

Most treatments for macular degeneration, like anti-VEGF injections, aim to slow vision loss by blocking harmful protein overgrowth in the eye. But FWY003 introduces a fresh approach; it targets a different pathway that could improve vision more effectively. Researchers are excited about FWY003 because it could offer a new mechanism of action, potentially leading to better outcomes for patients who don't respond well to current therapies. Additionally, its diverse dosing levels allow for more personalized treatment, possibly reducing side effects.

What evidence suggests that FWY003 might be an effective treatment for macular degeneration?

Research shows that FWY003 is under investigation as a potential treatment for geographic atrophy (GA), a condition associated with age-related macular degeneration (AMD). Earlier studies found that FWY003 may slow the progression of GA, which is crucial because GA can lead to vision loss. Specifically, some participants in those studies experienced a reduction in the size of damaged retinal areas. This suggests that FWY003 might help preserve vision for a longer period. Although further research is necessary to confirm these results, the early findings offer hope for individuals with GA due to AMD.12346

Are You a Good Fit for This Trial?

This trial is for men and women aged 50 or older who have geographic atrophy (GA) due to age-related macular degeneration in at least one eye. Their vision must be at least 20/200 in the study eye, and the area of GA must fall within a specific size range.

Inclusion Criteria

I am 50 years old or older.
* ETDRS BCVA ≥ 35 letters (20/200) in the study eye.
1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FWY003 or placebo to assess efficacy and safety over 18 months

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • FWY003

Trial Overview

The study compares FWY003, an investigational drug, with a placebo to see how well it works and how safe it is for people with GA from AMD. Participants are randomly assigned to receive either FWY003 or placebo.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: FWY003 dose level 3Experimental Treatment1 Intervention
Group II: FWY003 dose level 2Experimental Treatment1 Intervention
Group III: FWY003 dose level 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

A Study to Investigate Efficacy and Safety of FWY003 ...

This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy ...

A Study to Investigate Efficacy and Safety of FWY003 ...

A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration.

FWY003 for Macular Degeneration

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

A study to evaluate the safety and effectiveness of fwy003 ...

This study is being conducted to evaluate the effects of the drug FWY003 in individuals living with geographic atrophy caused by age-related macular ...

FWY003 - Drug Targets, Indications, Patents

A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in ...

Safety and Efficacy of ATG003 in Patients With AMD ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...