A clinical study to evaluate the health of the cornea in people with neovascular age-related macular degeneration who receive an eye implant that continuously delivers a drug called ranibizumab into the back of the eye
A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
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Eye Disorder -
Neovascular Age-related Macular Degeneration -
Wet Age-Related Macular Degeneration
Basic Details
1. Why is this study needed?
Age-related macular degeneration (AMD) is a condition that causes blurred or reduced central vision in one or both eyes. There are two forms of AMD depending on how the back of the eye (known as the macula) is damaged, ‘dry AMD’ and ‘neovascular AMD’ (also called wet AMD). In wet AMD, a chemical produced by the body called vascular endothelial growth factor (VEGF) causes abnormal blood vessels to be formed in the eye that can leak fluid onto the back of the eye and affect vision.
Wet AMD can be treated by injecting a type of drug called anti-VEGF (e.g. ranibizumab), into the eye (also known as an intravitreal injection). However, many people find anti-VEGF intravitreal injections burdensome, as they are given as often as every 1‒2 months. To reduce this burden, a refillable eye implant was designed that continuously releases ranibizumab over time, with refills of ranibizumab approximately every 6 months. This is called the port delivery system with ranibizumab. After testing in previous trials, the port delivery system with ranibizumab is now approved for the treatment of wet AMD.
This study aims to monitor the health of the cornea and evaluates if continuous release of ranibizumab from the eye implant impacts the health of the cornea.
2. Who can take part in the study?
People can take part in this study if they are at least 50 years old, have been diagnosed with wet AMD before screening, and have responded to at least 2 intravitreal anti-VEGF injections.
People may not be able to take part in this study if they have had previous eye surgery, received certain treatments, or have a history of certain other medical conditions.
People who are pregnant, planning to become pregnant, or currently breastfeeding cannot take part in the study.
3. How does this study work?
People will be screened to check if they are able to participate in the study. The screening period will take place from up to 28 days before the start of treatment.
This is an open-label study. This means everyone involved, including the participant and the study doctor, will know the study treatment the participant has been given.
One eye will be chosen as the ‘study eye’, and all participants in this study will receive the refillable eye implant, pre-filled with ranibizumab, in the study eye using a surgical procedure. This procedure takes around 30 minutes. The eye implant will then be refilled with ranibizumab at Week 24 and Week 48, during a procedure in the clinical trial doctor’s clinic that takes typically less than 15 minutes. If the treatment is not having the desired effect, participants may receive an extra intravitreal injection of ranibizumab at the clinical trial specified visits (Week 16 and Week 40 or possibly at Week 20 and Week 44). Participants will have approximately 13 clinic visits, and these may last 2‒4 hours. During these visits, the study doctor will see how well the treatment is working and any unwanted effects participants may have. Total time of participation in the study will be about 1 year. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so.
4. What are the main results measured in this study?
The main result measured in the study is to monitor the health of the cornea and to evaluate if continuous release of ranibizumab from the eye implant impacts the health of the cornea at Week 48 in the study eye. Photographs of the cornea are taken using a special microscope called specular microscopy; images allow for the examination of the cornea. Other key results measured in the study include to monitor the health of the cornea at Week 24 in the study eye, and the maintenance of vision at Week 24 and Week 48 in the study eye.
5. Are there any risks or benefits in taking part in this study?
Taking part in the study may or may not make participants feel better. But the information collected in the study can help other people with similar health conditions in the future.
The study involves some risks to the participant. But these risks are generally not greater than those related to routine medical care or the natural progression of the health condition. People interested in taking part will be informed about the risks and benefits, as well as any additional procedures or tests they may need to undergo. All details of the study will be described in an informed consent document. This includes information about possible effects and other options of treatment.
Risks associated with the study drug and device
Participants may have unwanted effects of the drug and device used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants will have regular check-ups to see if there are any unwanted effects.
Ranibizumab
Participants will be told about the known unwanted effects of ranibizumab, and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include inflammation in the eye, bleeding in the back of the eye, small particles or spots in your vision, increased tear production, increased pressure in eye, visual disturbances, itchy eye, and eye pain.
The study medicine may be harmful to an unborn baby. Women must take precautions to avoid exposing an unborn baby to the study treatment.
Port Delivery System
Participants will be told about any known unwanted effects of the port delivery system, a refillable eye implant, and where relevant, also potential unwanted effects based on human and laboratory studies or knowledge of similar devices. Known unwanted effects include separation of one of the layers in the back of your eye, bleeding in your eye, infection of the eyeball, and long-term presence of the eye implant may lead to delayed damage to the outside of the eye or infection of the eyeball with inflammation of the inside of the eye. The port delivery system will be implanted in the eye using a surgical procedure in an operating room. The eye will be numb before the procedure; the duration of the procedure takes around 30 minutes. Participants will be told about any known unwanted effects of the procedures involved in inserting, filling, refilling and removing (if needed) the eye implant device and, where relevant, potential unwanted effects based on human and laboratory studies or knowledge of similar procedures.
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
For the latest version of this information please go to www.forpatients.roche.com