Study on Long-Term Safety and Effects of Pegcetacoplan for Patients with Geographic Atrophy from Age-Related Macular Degeneration

3 1 1

What is this study about?

This clinical trial is focused on studying a condition called Geographic Atrophy, which is a form of Age-Related Macular Degeneration (AMD). AMD is an eye disease that can lead to vision loss in older adults. The treatment being tested in this study is called Pegcetacoplan, also known by its code name APL-2. Pegcetacoplan is administered as a solution for injection directly into the eye, a method known as intravitreal use.

The purpose of this study is to evaluate the long-term safety and effectiveness of Pegcetacoplan in individuals with Geographic Atrophy due to AMD. Participants in this study will receive regular injections of Pegcetacoplan over a period of time. The study will monitor the safety of the treatment and its impact on the progression of the disease. Participants will undergo various assessments to track changes in their vision and the condition of their eyes.

This study is an extension of previous research, meaning it continues to follow participants who have already been involved in earlier trials of Pegcetacoplan. The goal is to gather more information about how the treatment works over a longer period and to ensure it remains safe for use. Participants will be closely monitored by healthcare professionals throughout the study to ensure their well-being and to collect valuable data on the treatment’s effects.

1 joining the study

Participation begins after completing a previous study or treatment phase related to geographic atrophy secondary to age-related macular degeneration.

Eligibility is confirmed based on specific criteria, including eye health and, for women, a negative pregnancy test.

2 initial assessment

An initial assessment is conducted to ensure clarity of ocular media and adequate pupillary dilation.

Good quality images of the eyes are collected for evaluation.

3 treatment administration

The medication pegcetacoplan is administered as a solution for injection directly into the eye (intravitreal use).

The frequency and duration of administration are determined by the study protocol.

4 ongoing monitoring

Regular monitoring is conducted to assess the safety and effects of the treatment.

This includes measuring the area and growth rate of geographic atrophy lesions using imaging techniques.

5 vision assessments

Vision is evaluated using various tests, such as reading speed and visual acuity charts.

Additional assessments may include measuring macular sensitivity and other eye function parameters.

6 completion of study

The study is expected to conclude by June 2025.

Final assessments are conducted to evaluate the long-term safety and efficacy of the treatment.

Who Can Join the Study?

  • The study is for people with a condition called Geographic Atrophy due to Age-Related Macular Degeneration. This is a specific eye condition.
  • You must have participated in a previous study called APL2-103 or completed treatment in studies APL2-303 or APL2-304. If you missed the last visit in these studies, you can still join if you are screened within 60 days of the last expected visit.
  • Your eyes must be clear enough to allow good quality images to be taken, as decided by the study doctor. This applies to the other eye that is not being studied.
  • If you are a woman, you must either be unable to have children or, if you can have children, you must have a negative pregnancy test before starting and agree to use birth control during the study and for 90 days after the last dose. You must also agree not to breastfeed during the study.
  • If you are a man with a female partner who can have children, you must agree to use birth control and not donate sperm during the study and for 90 days after the last dose.
  • You must be willing and able to give informed consent, which means you understand the study and agree to follow the study procedures and assessments.

Who Cannot Join the Study?

  • Patients who have any other eye diseases that could affect the study results.
  • Patients who have had eye surgery within the last three months.
  • Patients who are currently using other treatments for eye conditions that are not allowed in the study.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who have any serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Augenzentrum Am St Franziskus-Hospital Muenster Munster Germany
Instituto Oftalmologico Gomez-Ulla S.L. Santiago De Compostela Spain
Centrum Medyczne Uno-Med Sp. z o.o. Tarnow Poland
Osrodek Chirurgii Oka Prof.Zagorskiego Sp. z o.o. Rzeszow Poland
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L. Paris France
Retina Saint-Cyr-Sur-Loire France
Centre Monticelli Paradis D Ophtalmologie Marseille France
Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic Paris France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Quinze-Vingts National Ophthalmology Hospital Paris France
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Pole Vision Val D’Ouest Ecully France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hopital Beaujon Clichy France
University Hospital Ostrava Ostrava Czechia
Ophtalmologie Maison Rouge S.C.M. STRASBOURG, Alsace France
Oftalmika Sp. z o.o. Bydgoszcz Poland
Ahvb Cbqjubct srhwzp Prague Czechia
Gymyzr oayy kethugm angs Zlin Czechia
Ovxxqpsvxbf Spv z oaye Bydgoszcz Poland
Uncrnhdraq Honbhshf Crgajux Cologne Germany
Ceekto Hugfwkpdtdq Upsozbcjnjpvn Dr Dstxu Dijon France
Adthrbgtf Ufn Amsterdam The Netherlands
Ssybfcnec Rtftleu Uwtcnvrmgc Mudyljh Cwsixa Nijmegen The Netherlands
Ufqhxzshqjlhdrbtrctdh Mtaiadxu Aol Munster Germany
Kblvpdmy did Upoofzorxthd Mdwatmcu Asc Munich Germany
Cfs Cvcca Rlynmzvnfxn Lyon France
Hsatnoax Uitsifcvjlkurs Stoeqnnxry &gedwmn Hfvgkfq dn Hnribtwztlj STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
04.03.2021
France France
Not recruiting
04.03.2021
Germany Germany
Not recruiting
04.03.2021
Italy Italy
Not recruiting
04.03.2021
Poland Poland
Not recruiting
04.03.2021
Spain Spain
Not recruiting
04.03.2021
The Netherlands The Netherlands
Not recruiting
04.03.2021

Trial locations

Investigated drugs:

Pegcetacoplan is a medication being studied for its long-term safety and effectiveness in treating geographic atrophy, which is a condition related to age-related macular degeneration. This medication is administered through an injection into the eye, and the study aims to understand how well it works and how safe it is for patients over an extended period.

Geographic Atrophy Secondary to Age-Related Macular Degeneration – This disease is a progressive eye condition that affects the central part of the retina, known as the macula, leading to vision loss. It is a form of age-related macular degeneration where the retinal cells gradually deteriorate, causing patches of atrophy or thinning. Over time, these patches expand, resulting in a gradual decline in central vision, which is crucial for tasks like reading and recognizing faces. The progression of the disease can vary, with some individuals experiencing a slow decline, while others may notice more rapid changes. Peripheral vision usually remains intact, but the loss of central vision can significantly impact daily activities.

Trial ID:
2024-512945-18-00
Protocol code:
APL2-GA-305
NCT ID:
NCT04770545
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • FWY003 in Geographic Atrophy Secondary to Age-Related Macular Degeneration in Patients

    Recruiting

    2 1
    Bulgaria Czechia France Germany Hungary Italy +3
  • Study of ONL1204 eye injections to slow vision loss in patients with age-related macular degeneration and geographic atrophy

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany Greece Hungary Italy +3