Study on Long-Term Safety of Ranibizumab for Patients with Wet Age-Related Macular Degeneration Using a Port Delivery System

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a treatment for Neovascular Age-Related Macular Degeneration (nAMD), a condition that affects the eyes and can lead to vision loss. The treatment being studied involves the use of a medication called Ranibizumab, which is delivered through a special device known as the Port Delivery System. This system allows the medication to be released into the eye over an extended period, potentially reducing the need for frequent injections.

The purpose of the study is to evaluate how safe and well-tolerated this method of delivering Ranibizumab is for patients with nAMD. Participants in the study will receive the treatment every 24 or 36 weeks, depending on the specific group they are assigned to. The study will monitor participants over a long period to gather information on any side effects or issues that may arise from the treatment. This will help researchers understand the potential benefits and risks associated with using the Port Delivery System for managing nAMD.

Throughout the study, participants will undergo regular check-ups to assess their vision and overall eye health. These assessments will help determine any changes in vision and identify any adverse effects related to the treatment. The study aims to provide valuable insights into the long-term use of the Port Delivery System with Ranibizumab for individuals with Neovascular Age-Related Macular Degeneration.

1 initial implantation

The study involves the use of a device called the Port Delivery System with ranibizumab. This device is implanted in the eye to deliver medication over time.

The medication used is ranibizumab, which is a solution for injection. It is administered through implantation.

2 medication administration

The Port Delivery System releases ranibizumab at a concentration of 100 mg/mL.

The medication is delivered every 24 weeks or every 36 weeks, depending on the specific requirements of the study.

3 follow-up visits

Regular follow-up visits are scheduled to monitor the safety and tolerability of the treatment.

These visits include assessments of visual acuity and any potential side effects.

4 monitoring for adverse events

The study monitors for any adverse events, both ocular (related to the eye) and systemic (affecting the rest of the body).

Special attention is given to any adverse events of special interest, particularly during the postoperative period and the follow-up period.

5 visual acuity assessments

Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.

The study tracks changes in visual acuity over time, including the percentage of patients who experience specific changes in their vision.

6 study duration

The study is expected to continue until December 31, 2029.

Participants are monitored throughout the study to ensure the long-term safety and effectiveness of the treatment.

Who Can Join the Study?

  • The patient must have previously participated in and completed either Study GX28228 (Ladder) or Study GR40548 (Archway) without stopping early or needing early treatment. This includes those who received monthly eye injections of ranibizumab (a medication used to treat certain eye conditions) or had an implant. Alternatively, the patient could have been part of Study WR42221 (Velodrome) and either not been eligible for randomization at Week 24 or completed the study.
  • The patient must be able and willing to attend all scheduled visits and assessments.
  • If the patient is a woman who can have children, she must agree to either not engage in heterosexual intercourse or use birth control methods during the treatment period. This should continue for at least 3 months after the last eye injection of ranibizumab or 1 year after the last implant refill or exchange of ranibizumab.

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 have an eye infection or inflammation.
  • Patients who are allergic to the study medication or any of its ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a serious illness that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a condition that makes it difficult to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
ASST Fatebenefratelli Sacco Milan Italy
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Kommunale Traegergesellschaft Cottbus mbH Cottbus Germany
Knappschaft Kliniken Saar GmbH Sulzbach Germany
Augenzentrum Am St Franziskus-Hospital Muenster Munster Germany
Selarl Retine Tourny Bordeaux France
Centre Monticelli Paradis D Ophtalmologie Marseille France
Instituto Oftalmologico Fernandez-Vega S.L. Oviedo Spain
Oftalmologia Vistahermosa S.L. Burjassot Spain
Clinica Baviera S.A. Madrid Spain
Centro De Oftalmologia Barraquer S.A. Barcelona Spain
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
Fondation A De Rothschild Paris France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Ludwig Maximilian University Of Munich Munich Germany
Universita’ Politecnica Delle Marche Ancona Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Cliniche Gavazzeni S.p.A. Bergamo Italy
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Ufmecmsdvl Msasspn Cbslhd Htmftnycthemqyube Hamburg Germany
Uiznqvzptk Hvgesywl Cudrlkd Cologne Germany
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Uajmexafwtqnlplqoillt Muhqgaue Ail Munster Germany
Cso Clqbn Rxmxfraysrn Lyon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
22.08.2022
Belgium Belgium
Not recruiting
22.08.2022
France France
Recruiting
22.08.2022
Germany Germany
Recruiting
22.08.2022
Italy Italy
Recruiting
22.08.2022
Spain Spain
Recruiting
22.08.2022

Trial locations

Investigated drugs:

Ranibizumab is a medication used to treat neovascular age-related macular degeneration, a condition that can lead to vision loss. In this clinical trial, ranibizumab is delivered through a special device called the Port Delivery System. This system allows the medication to be released slowly over time, reducing the need for frequent injections. The trial aims to assess how safe and tolerable this method of delivery is for patients over a long period.

Neovascular Age-Related Macular Degeneration (nAMD) – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause the macula to lift from its normal position, resulting in rapid and severe vision loss. The disease typically progresses with symptoms such as blurred vision, dark spots in the center of vision, and distorted vision. Over time, if untreated, it can lead to significant central vision impairment, although peripheral vision usually remains unaffected. The progression of nAMD can vary, with some individuals experiencing a slow decline in vision, while others may notice a rapid deterioration.

Trial ID:
2023-507131-38-00
Protocol code:
GR40549
Trial Phase:
Therapeutic confirmatory (Phase III)

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