Study of OPT-302 and Aflibercept 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 using a combination of two medications: OPT-302 and aflibercept. Aflibercept is already used to treat wet AMD, and the trial aims to see if adding OPT-302 can improve outcomes for patients.

The purpose of the study is to evaluate the effectiveness and safety of this combination treatment compared to using aflibercept alone. Participants in the study will receive injections directly into the eye, a method known as intravitreal use. The study will last for a period of 96 weeks, during which participants will receive regular injections and have their vision monitored to assess any changes.

Throughout the study, some participants will receive a placebo, which is a treatment that looks like the real medication but does not contain any active ingredients. This helps researchers understand the true effects of the medications being tested. The study will measure changes in vision and other eye health indicators to determine the success of the treatment. The goal is to find out if the combination of OPT-302 and aflibercept can provide better results for people with wet AMD.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age and eye condition.

Participants must be at least 50 years old and have a specific type of eye condition related to age-related macular degeneration.

2 initial assessment

An initial assessment is conducted to establish a baseline for visual acuity using a standardized test.

This assessment helps in measuring changes in vision throughout the study.

3 treatment administration

Participants receive an injection of aflibercept (2.0 mg) into the eye, which is a medication used to treat the eye condition.

Some participants also receive an additional injection of OPT-302 (2.0 mg) to evaluate its combined effect with aflibercept.

The injections are administered directly into the eye, a method known as intravitreal use.

4 follow-up visits

Regular follow-up visits are scheduled to monitor the condition and any changes in vision.

These visits include visual acuity tests and imaging of the eye to assess the treatment’s effectiveness.

5 final assessment

At the end of the study period, a final assessment is conducted to measure the overall change in vision.

The primary goal is to determine the mean change in visual acuity from the start of the study to the end.

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 eye being studied. A CNV lesion is an area in the eye where abnormal blood vessels grow, and foveal involvement means it affects the central part of the retina responsible for sharp vision.
  • Participants must have an ETDRS BCVA score between 60 and 25 letters in the eye being studied. This score is a way to measure vision clarity, with a higher number indicating better vision.

Who Cannot Join the Study?

  • Patients who have any other eye diseases that could affect the study results.
  • Patients who have had eye surgery in the last three months.
  • Patients who are currently receiving treatment for another eye condition.
  • Patients who have a history of severe allergic reactions to medications used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have had a stroke or heart attack in the last six months.
  • Patients who have any serious health conditions that could interfere with the study.
  • Patients who are participating in another clinical trial.
  • 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
Azienda Ospedaliero Universitaria Careggi Florence Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Pauls Stradins Clinical University Hospital Riga Latvia
ASST Fatebenefratelli Sacco Milan Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Santa Maria Della Misericordia Perugia Italy
University Hospital Bratislava Bratislava Slovakia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Santa Sp. z o.o. Lodz Poland
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
University General Hospital Of Heraklion Heraklion Greece
MBAL Trakia EOOD Stara Zagora Bulgaria
Nozologen Kft. Pecs Hungary
The Rotterdam Eye Hospital Rotterdam The Netherlands
Institut Catala De Retina S.L. Barcelona Spain
Instituto Oftalmologico Fernandez-Vega S.L. Oviedo Spain
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
Fakultna Nemocnica Trencín Trencin Slovakia
General University Hospital Of Larissa Larissa Greece
University Of Debrecen Debrecen Hungary
Clinical Medical Center Osijek Osijek Croatia
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Fakultna Nemocnica S Poliklinikou Zilina Zilina Slovakia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
East Tallinn Central Hospital Tallin Estonia
University Of Pecs Pecs Hungary
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
KBC Split Split Croatia
Hopital Beaujon Clichy France
Fakultni Thomayerova nemocnice Prague Czechia
Oftalmika Sp. z o.o. Bydgoszcz Poland
Silmalaser OÜ Tallin Estonia
Silmaarst Krista Turman OÜ Tallin Estonia
Adua Ccaoucow sqxmun Prague Czechia
Ockqenxhmsha Pabfeugroen Dqm Budka djksen Osijek Croatia
Psvvbpkcne Cfothsd Wutnnp Mdrov Mrpvfc Mxrhlbt Mwsyli Sji ji Poznan Poland
Ojppwmhbbns Snz z odll Bydgoszcz Poland
Syplrtx Szlfpskk Lxkqgdl Sxni Bielsko-Biala Poland
Npvtffxhw S Pkapyorxmgfz Thyjvner avib Trebisov Slovakia
Fnexsxmti Pzea Et Ffwglmx Dm Lk Ifhwatrbtwizx Sakcmuvup Y Brsqzujut Do Ln Cpjclwtay Vogqamgydc Valencia Spain
Ciryhq Hodpvycjpvt Uvhsoyybutvzx Da Dbsqx Dijon France
Slf Eyltpcdoo Hgwllakc Tlxaixf Tilburg The Netherlands
Rzdao Azppxtsa kodrsxen urzdsgkbemoye ssendgwh Sdw Riga Latvia
Hnspglld Uxhxpzcomxkad Hghjssuo Ttmyv y Pxievr Iddgdsiz Cogdpk ddunpunqaxgiqtqhc (yepz Badalona Spain
Hyxrukhj Vulq dcyigmuf Barcelona Spain
Gtmefwe Ozbneesifwxu Jyayt Mkdaytneqw Lublin Poland
Ukjrhfkkjc Gkjgwfk Haiqypuz Acpmcdg Athens Greece

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
04.10.2021
Bulgaria Bulgaria
Not recruiting
04.10.2021
Croatia Croatia
Not recruiting
04.10.2021
Czechia Czechia
Not recruiting
04.10.2021
Estonia Estonia
Not recruiting
04.10.2021
France France
Not recruiting
04.10.2021
Germany Germany
Not recruiting
04.10.2021
Greece Greece
Not recruiting
04.10.2021
Hungary Hungary
Not recruiting
04.10.2021
Italy Italy
Not recruiting
04.10.2021
Latvia Latvia
Not recruiting
04.10.2021
Lithuania Lithuania
Not recruiting
04.10.2021
Poland Poland
Not recruiting
04.10.2021
Slovakia Slovakia
Not recruiting
04.10.2021
Spain Spain
Not recruiting
04.10.2021
The Netherlands The Netherlands
Not recruiting
04.10.2021

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 purpose of this medication in the trial is to evaluate its effectiveness and safety when used in combination with another medication, aflibercept, to improve vision in patients with nAMD.

Aflibercept is a medication already used to treat neovascular age-related macular degeneration (nAMD). It works by blocking the growth of abnormal blood vessels in the eye, which can help prevent vision loss. In this trial, aflibercept is used both alone and in combination with OPT-302 to compare the outcomes and determine if the combination provides better results for patients with nAMD.

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 the macula to lift from its normal position, damaging the retina and leading to vision loss. The disease progresses as these abnormal blood vessels continue to grow and leak, further impairing vision. Over time, this can result in significant vision impairment if not managed. Wet AMD is one of the leading causes of vision loss in older adults.

Trial ID:
2024-512880-30-00
Protocol code:
OPT-302-1005
NCT ID:
NCT04757636
Trial Phase:
Therapeutic confirmatory (Phase III)

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