Ended Therapeutic confirmatory (Phase III) geographic atrophy

An Open-Label Extension Study for Patients who Previously Completed Study ISEE2008 (GATHER2)

EU CTIS ID: 2024-515185-13-00

What this study is testing

The objectives of this trial are to assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment, regardless of whether they received treatment with avacincaptad pegol or Sham previously, refer to Section 8.2 of the ISEE2008 protocol for inclusion criteria details. Patients must provide new written informed consent for this OLE trial prior to participating and have the ability to return for all trial visits for the duration of the 18-month trial.

You likely can't join if

  • 1. Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham)
  • 2. Any patients who had the study drug permanently withdrawn for an AE are not eligible; patients who had study drug temporarily withheld for an AE(s) or elective ocular surgery will be reviewed on case by case basis for eligibility
  • 3. Patient did not enroll into this OLE trial within the 90 days enrollment period.
  • 4. Patients who are pregnant or nursing

The study team makes the final eligibility decision.

Where it's taking place

  • Argentina
  • Israel
  • Brazil
  • United States
  • Canada
  • Australia
  • Colombia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; Israel; Brazil; United States; Canada; Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.