A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
This research study is investigating a new treatment for neovascular age-related macular degeneration, often called 'wet' AMD. This condition affects your central vision. The study aims to find out if a new drug called OPT-302, when given together with an existing treatment called Lucentis, is more effective and safe than Lucentis on its own. Researchers will be looking at changes in participants' vision over 52 weeks to see if the combination treatment helps people see better or stops their vision from getting worse. This is a large-scale study, comparing the new combination with the standard treatment to confirm its potential benefits.
At a glance
What is this study about?
This clinical trial is designed to investigate a new approach to treating 'wet' age-related macular degeneration (AMD). AMD is a common eye condition that can cause blurry vision or a blind spot in the centre of your vision, making everyday tasks like reading or recognising faces difficult. In 'wet' AMD, abnormal blood vessels grow under the retina (the light-sensing tissue at the back of your eye) and leak, damaging your vision.
The study compares two ways of treating 'wet' AMD. One group of participants will receive the standard treatment, which involves an eye injection of a medicine called Lucentis. The other group will receive Lucentis alongside a new investigative medicine called OPT-302, also given as an eye injection. Both the patients and the doctors won't know who is receiving which treatment, which helps ensure the study results are fair and unbiased.
The main goal is to see if combining OPT-302 with Lucentis leads to a greater improvement in vision compared to Lucentis alone, or if it's better at stopping vision loss over one year. Researchers will measure vision using a standard eye chart and also look at detailed scans of the eye to see how the treatments affect the abnormal blood vessels and any fluid under the retina. This type of study, known as Phase 3, is usually the final step before a new treatment can be considered for wider use.
Key takeaways
- This study evaluates a potential new combination treatment for 'wet' AMD.
- It aims to see if OPT-302 plus Lucentis is better than Lucentis alone for vision.
- Participation involves regular eye injections and eye checks over one year.
- The study is 'double-masked', meaning you won't know which treatment you receive.
- It's a Phase 3 study, meaning it's a key step towards potential new treatments.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
The study is specifically looking for people who have been diagnosed with 'wet' age-related macular degeneration (wet AMD). There will be other specific medical criteria that need to be met to ensure the treatment is suitable and safe for you, and that the study results are as clear as possible.
Your eye doctor will be able to tell you if you meet all the necessary requirements to take part in this research. They will review your medical history and conduct eye examinations to determine if this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with 'wet' age-related macular degeneration (wet AMD)?
- Are you able to attend regular clinic visits and receive eye injections for about a year?
- Are you willing to potentially receive either the standard treatment or the new combination treatment?
What does participation involve?
If you decide to take part, you will have regular visits to the clinic over a period of 52 weeks (about one year). During these visits, you will have several eye examinations, including vision tests using eye charts and detailed scans of your eye. You will also receive regular eye injections of either Lucentis on its own or Lucentis combined with OPT-302. The schedule for these injections and follow-up checks will be carefully explained to you by the study team. At each visit, your overall health and any potential side effects will be monitored closely.
Potential risks and benefits
Locations (10)
- —UnverifiedHungary
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedLatvia
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGreece
Common questions
What is 'wet' AMD?
'Wet' Age-related Macular Degeneration (AMD) is an eye condition where abnormal blood vessels grow under the retina, causing fluid leakage and affecting your central vision.
What is the new drug being tested?
The new drug is called OPT-302. It's being tested alongside an existing treatment, Lucentis, to see if the combination works better for 'wet' AMD.
How will my vision be measured?
Your vision will be measured using a special eye chart (ETDRS BCVA) and detailed eye scans (like OCT and fluorescein angiography) throughout the study.
Will I know which treatment I'm getting?
No, this is a 'double-masked' study, meaning neither you nor your study doctor will know if you're receiving Lucentis alone or Lucentis with OPT-302. This helps keep the results fair.
How long will the study last?
The main part of the study where your vision is tracked will last for 52 weeks, which is about one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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