Study on the Effectiveness of OPT-302 and Ranibizumab for Patients with Wet Age-related Macular Degeneration

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What is this study about?

This clinical trial is focused on studying a condition called neovascular age-related macular degeneration, often referred to as wet AMD. This is a common eye disease that can lead to vision loss in older adults. The study is testing a new treatment approach that combines two medications: OPT-302 and ranibizumab. OPT-302 is a solution for injection that targets specific proteins involved in the growth of abnormal blood vessels in the eye. Ranibizumab is a well-known medication already used to treat wet AMD, and it is also given as an injection into the eye.

The purpose of this study is to evaluate how effective and safe the combination of OPT-302 and ranibizumab is compared to using ranibizumab alone. Participants in the study will receive regular injections of these medications over a period of time. Some participants will receive both OPT-302 and ranibizumab, while others will receive only ranibizumab. There is also a possibility of receiving a placebo, which is an inactive substance. The study will monitor changes in vision and eye health to determine the effectiveness of the treatment.

Throughout the study, participants will have regular check-ups to assess their vision and the condition of their eyes. The study aims to see if the combination of these medications can improve vision more effectively than the standard treatment alone. This research could potentially lead to better treatment options for people with wet AMD, helping to preserve their vision and improve their quality of life.

1 joining the study

Upon joining the study, participants are required to meet specific criteria, including being at least 50 years old and having a certain type of eye condition related to age-related macular degeneration (AMD).

2 initial assessment

An initial assessment is conducted to evaluate the condition of the eye. This includes measuring visual acuity using a standardized test known as ETDRS BCVA, which assesses the ability to read letters on a chart.

3 treatment administration

Participants receive an injection of OPT-302 combined with ranibizumab or ranibizumab alone. The injection is administered directly into the eye, a method known as intravitreal use.

The dosage for OPT-302 is 2.0 mg, and for ranibizumab, it is 0.5 mg. These injections are given as part of the treatment plan for neovascular AMD.

4 follow-up visits

Regular follow-up visits are scheduled to monitor the progress of the treatment. These visits include assessments similar to the initial evaluation, focusing on changes in visual acuity and the condition of the eye.

5 final assessment

At the end of the study period, a final assessment is conducted to determine the overall effectiveness of the treatment. This includes measuring the change in visual acuity from the start of the study to the end, approximately 52 weeks later.

Who Can Join the Study?

  • Participants must be male or female and at least 50 years old.
  • Participants must have an active subfoveal CNV lesion or a juxtafoveal CNV lesion with foveal involvement in the study eye. This means there is a problem with the blood vessels in the eye related to age-related macular degeneration (AMD).
  • Participants must have an ETDRS BCVA score between 60 and 25 letters in the study eye. This score is a way to measure how well you can see.

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 receiving or have received certain treatments for eye conditions in the past three months.
  • Patients with a history of severe allergic reactions to any of the study medications.
  • Patients who have uncontrolled high blood pressure.
  • Patients with any serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Eb Group Sp. z o.o. Warsaw Poland
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Oftex s.r.o. Pardubice Czechia
Oftalmologia Vistahermosa S.L. Burjassot Spain
Centro De Oftalmologia Barraquer S.A. Barcelona Spain
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
University General Hospital Of Ioannina Ioannina Greece
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nice Nice France
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Rigshospitalet Copenhagen Denmark
Pole Vision Val D’Ouest Ecully France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Area De Salud De Burgos Y Soria Burgos Spain
Budapest Retina Associates Budapest Hungary
Knsrpsz Jb My seqrca Prague Czechia
Mjidups Pjkcbmh Cjpi sdhjgx Sokolov Czechia
Chtkwnfbg Sbx z ojdy Tarnowskie Gory Poland
Cxkqtle Mbfiofex Dzzkzt 1x Smy z obke Cracow Poland
Ilbpebnvj Di Mgmhwureijcc Ogamnu Dve Srcl Barcelona Spain
Lnzwt Gzvmmti Hguzddni On Avavdm Athens Greece
Uobmdqepsxrxd Suyqlrn Kozeaagso Nm 2 Psk W Szjdpvtcdn Szczecin Poland
Agdriry Ocpumpgwogs Uzleziesqvswr Sokpip Siena Italy
Atcipe Udcqqdpzcb Hngykyyp Aarhus Denmark
Uqgknhnvfllkfcrcvprvc Mmntsvno Adh Munster Germany
Abwimpu Ulbsz Svldauefq Lvgmao Dd Bwlunci Bologna Italy
Uexalrddyp Mpjtp Gwtfrbe Os Crrcohvod Catanzaro Italy

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
27.09.2021
Denmark Denmark
Not recruiting
27.09.2021
France France
Not recruiting
27.09.2021
Germany Germany
Not recruiting
27.09.2021
Greece Greece
Not recruiting
27.09.2021
Hungary Hungary
Not recruiting
27.09.2021
Italy Italy
Not recruiting
27.09.2021
Latvia Latvia
Not recruiting
27.09.2021
Poland Poland
Not recruiting
27.09.2021
Spain Spain
Not recruiting
27.09.2021

Trial locations

OPT-302 is an investigational medication being studied for its potential to treat neovascular age-related macular degeneration (nAMD). It is administered through an injection into the eye, known as an intravitreal injection. The goal of using OPT-302 is to improve vision by targeting specific pathways involved in the disease process.

Ranibizumab is a medication commonly used to treat neovascular age-related macular degeneration (nAMD). It is also given as an intravitreal injection. Ranibizumab works by inhibiting a protein that contributes to the growth of abnormal blood vessels in the eye, which can lead to vision loss. In this study, it is used both alone and in combination with OPT-302 to evaluate the effectiveness of the combination therapy.

Neovascular Age-Related Macular Degeneration (Wet AMD) – This is a chronic eye disorder that causes blurred vision or a blind spot in your visual field. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause damage to the macula, the part of the retina responsible for central vision. As the disease progresses, it can lead to rapid and severe vision loss. Wet AMD is more severe than its counterpart, dry AMD, and can develop quickly. It primarily affects older adults and is a leading cause of vision loss in this age group.

Trial ID:
2024-512879-13-00
Protocol code:
OPT-302-1004
NCT ID:
NCT04757610
Trial Phase:
Therapeutic confirmatory (Phase III)

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