|Dry macular degeneration clinical trials are becoming more available as new treatments and earlier intervention is being researched.|
1. Where is the Study Being Conducted
The clinical trials that are listed at www.clinicaltrials.gov include studies that are offered in the United States as well as abroad. So it is important to look at the location of the study. Often the study will have several study locations.
2. What Phase Is the Study In
There are four phases of clinical trials. Phase 1 is the first stage that focuses on safety and recruits the smallest number of participants, while a Phase 2 is looking more at the effectiveness of the therapy.
A Phase 3 will recruit a larger population and will continue to
look at safety and effectiveness and may also evaluate different
Here is a sampling of some current dry macular degeneration clinical trials:
An ophthalmology company that's developing gene therapies in the UK called Gyroscope Therapeutics has just launched its first Phase I/II clinical trial to slow the progression of central vision loss in patients with dry AMD . The basis of their research involves the cascading effects of what is called the Complement System - complement system proteins, complement activators and complement regulatory proteins. These molecules stimulate and trigger inflammation and the progression of macular degeneration.
Recent genetic studies have identified and shown that there are gene variants that trigger an overactive complement system which is associated with the degeneration of the macula and progression of AMD.
The multi-center study in the United Kingdom will "evaluate the safety, the dose response and efficacy (anatomical and functional visual outcomes) of two doses of GT005 administered as a single subretinal injection in genetically defined subjects with Macular Atrophy due to Age-related Macular Degeneration (AMD)."
Pixum, a Paris based company has developed a system that may enhance vision by stimulating degenerated photoreceptor cells in patients with advanced dry macular degeneration. The system called Photovoltaic Retinal Implant (PRIMA) consists of 4 components.
1. A pair of glasses that include a miniature camera and a data transmitter
2. A miniature wireless subretinal chip
3. A pocket size digital signal processor that transforms light into electric signals
4. Software that can be individualized for each patient
This clinical trial is a feasibility study being conducted in France and the United States. The study in France has recruited and implanted the device in 5 patients. The first implant in France was performed January 25, 2018. On August 30, 2018 Pixium Vision Chief Executive officer Khalid Ishaque, stated: "The successful consecutive activations of PRIMA in all five implanted study patients, combined with the preliminary clinical results and progress with the first implanted patients, are very encouraging for the clinical development of PRIMA. We look forward to reporting on the continued progress of the feasibility study, including the interim six-months combined follow-up data for the five patients, and the next phases of clinical development of PRIMA in Europe and in the United States."
Here is a short video on how the Photovoltaic Retinal Implant system works:
You can go to www.ClinicalTrials.gov website to learn more about the study here:
Robin Guymer, ophthalmologist, retina specialist and deputy director of the Centre for Eye Research Australia is also the principal investigator of the Study of APL-2 Therapy in Patients with Geographic Atrophy (FILLY).
With 40 testing sites in the United States and Australia, 246 patients were recruited to receive either monthly or every other month eye injections of a new compound APL-2 for 12 months.
Eligible patients had a diagnosis of geographic atrophy, (GA) due to macular degeneration.
Phase 2 clinical trial results report, "Patients were given injections either monthly or every other month for 12 months, resulting in a reduction in GA lesion growth of 29 per cent and 20 per cent respectively, compared to control patients.
Additionally, in a post hoc analysis, a greater effect was observed during the second six months of the study: a reduction in GA lesion growth rate of 47 per cent with monthly administration, and a reduction of 33 per cent with every other month administration. Based on these positive results, Apellis plans to proceed with Phase 3 studies as soon as possible."
The National Eye Institute is looking to see if a common antibiotic, minocycline, will help those with geographic atrophy. (GA).
Dry macular degeneration has a slower progression of central vision loss due to the degeneration and loss of the retinal pigment epithelial (RPE) cells and photoreceptors in the macula.
According to the description from ClinicalTrials.gov, "While the etiology of GA is not completely understood, inflammatory processes involving the activation of resident immune cells of the retina called microglia is likely to contribute. Minocycline inhibits the activation of microglia which produce inflammatory factors implicated in GA development. The objective of this study is to investigate the safety and possible efficacy of oral minocycline in patients with GA."
Forty participants who have GA in one or both eyes will be enrolled in the study. A 100 mg dose of minocycline will be taken twice daily for 36 months. To find out more about this study visit:
The sponsor and collaborator of this dry macular degeneration clinical trial are Stanford University and Bascom Palmer Eye Institute. Eligible participants must be at least 60 years old and have dry macular degeneration and "large high-risk drusen." The goals of the study as stated by ClinicalTrial.gov are:
1. To determine if this treatment will reduce macular drusen volume
2. Whether treatment will improve visual acuity
3. If treatment will reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization (wet macular degeneration) or geographic atrophy.
Here is a short video explaining how the non-damaging laser unit called Pascal Laser Endpoint Management System can be used in retinal diseases without tissue damage.
This macular degeneration study is a double blind placebo controlled study meaning that participants will be randomized to receive the photo thermal therapy and others a "sham" laser treatment.
"Elamipretide is an investigational drug with the potential to modify disease through its apparent ability to restore normal energy production in damaged mitochondria, while decreasing oxidative stress, " explains Stealth BioTherapeutics, the sponsor of the above clinical trial.
Subjects who have one eye with intermediate AMD, including high-risk drusen without geographic atrophy (GA) and a subgroup of subjects with non-central GA will be recruited for this study. Since it is a Phase I study looking at safety and tolerability only 40 patients will be recruited.
Eligible patients must be 55 years and older with no evidence of wet macular degeneration - either active or a prior history of it in the study eye. There can be no evidence of a visually significant cataract or central GA involving the fovea. The drug, elamipretide, which targets mitochondrial dysfunction, will be administered once daily as a subcutaneous injection.
Stealth BioTherapeutics Inc is the sponsor of the study and the principal investigator is Scott W. Cousins, MD from the Dept of Ophthalmology at Duke Eye Center.Phase I Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects with AMD
Dr. Cousins reports on the role of mitochondrial dysfunction in the dry-age related macular degeneration in Retina Today: Role of Mitochondrial Dysfunction in Dry AMD
This clinical trial will evaluate the safety and response to one-time subretinal administration of Human Umbilical Tissue-Derived Cells (CNTO 2476) in patients who are experiencing vision loss due to geographic atrophy from dry macular degeneration.
Participants need to be 50 years old or older with a confirmed diagnosis of geographic atrophy in both eyes.
The sponsor is Janssen Research & Development, LLC and the study sites include Arcadia, California and Philadelphia, Pennsylvania.
ORACEA® is the name of the medication that is to be given as a capsule daily for 24 months at a dose of 40 mg.
To be eligible the patient needs to be 55 Years to 85 years old with a diagnosis of geographic atrophy as a result of dry macular degeneration in at least one eye.
There are several study center sites from Texas to Connecticut.
Lead investigator Professor Robyn Guymer, who conducted a pilot study of the nanosecond laser in 2010-12, said: “The results were encouraging so we have decided to conduct a much larger proof of principle randomized trial. Patients reported that the laser treatment was completely painless. A few even wondered when the treatment was going to start, when it was actually already over.”
The name of the current study is Laser Intervention in Early Age-Related Macular Degeneration Study (LEAD).
Check this study out here:
The Argus II is a system consisting of:
1. Implanted electrodes on the retina in a single eye
2. An external miniature video camera
3. A video processing unit
4. Eyeglasses that include a transmitter
The process begins with the video camera taking images that are then sent to the video processor. The processor wirelessly transmits the images as electrical impulses to the implanted electrodes. To watch a video to see how this device works go to:
Research for dry macular degeneration involves early intervention before vision begins to deteriorate and late intervention for those who have the advanced dry form of geographic atrophy.