Clinical Trials For Dry AMD

Clinical trials are the final research phase before a treatment is approved for the general public. Once a drug or treatment has been developed, it is testing in humans through a succession of clinical trials.

Research on treatments starts in the laboratory where scientists work to identify the processes involved. These are called Pre-Clinical studies. Clinical trials begin with Phase I trials, which test the treatment on a small number of people for safety and best dose. Phase II involves several hundred subjects to test for effectiveness. Phase III expands the study to thousands of people in order to confirm effectiveness and monitor safety and side effects. After the drug or treatment has been approved by the Food and Drug Administration (FDA) and made available for public use, studies continue to track side effects and success.

These clinical trials are recruiting patients to volunteer.  Participants in any clinical trial are chosen based on eligibility.  If you are interested in participating, ask your retinal specialist if you would be a good candidate.  Or, use the information in each section to contact the coordinator of the trial.  Some of these clinical trials have many sites throughout the U.S.  Others are in one location in the U.S. or in other countries.  You will always need to be examined before you are accepted and you must be available for appointments.

Clinical trials listed below are divided into three time frames. The first are the Clinical Trials that are still “Recruiting” patients to participate in the study. The second are the Trials that are currently in progress, but are “Not Recruiting” new patients. The last and final stage are those studies that are “Completed” already and have some results to report.

Lampalizumab-Recruiting

Lampalizumab (or anti-Factor D) is a drug that is injected into the eye. In earlier Phase II trials, it was shown to reduce the area of the geographic atrophy by 20%. A Phase III clinical trial is now underway for individuals with geographic atrophy from dry AMD. Several research sites are actively recruiting now and many others will start recruiting in the near future.

For more information, Clinical Trials.

November 2014

GSK933776 – Not Recruiting

The purpose of this Phase II study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to dry age-related macular degeneration.  The drug is given through intravenous infusion, at different dosages, or as a placebo.  The study is taking place at multiple locations in the U.S., but no more patients are being recruited.  It is sponsored by GlaxoSmithKline.

For more information, visit ClinicalTrials.gov.

June 2014


Fluocinolone Acetatonide Insert – Recruiting

This Phase II trial is a randomized, double-masked, fellow-eye comparison of the safety and efficacy of 0.2 and 0.5 µg/day fluocinolone acetonide intravitreal insert to sham injection in subjects with bilateral geographic atrophy due to AMD.  This is a sustained release insert.  The study is sponsored by Alimera and is taking place in multiple sites across the United States.

For more information, visit ClinicalTrials.gov.

November 2014


MacuCLEAR Eyedrops – Recruiting

This is a Phase II/III, double masked, single center study. A single eye of 60 individuals with mild to moderate dry Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a placebo over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients.  The trial takes place in Utah.

For more information, visit ClinicalTrials.gov.

June 2014


Bone Marrow Stem Cells CD34+

In this Phase 1 clinical trial, participants will be treated with intravitreal injection of  CD34+ stem cells isolated from bone marrow.  The patient receives stem cells derived from his own bone marrow.  This study will determine whether there are any major safety and feasibility concerns.   Patients will be followed for 6 months after treatment, including eye examinations and imaging.  Macular degeneration is one of the retinal diseases being studied with this method.  The study takes place at the University of California in Davis, CA.

For more information, visit ClinicalTrials.gov.

June 2014


Stem Cells – ACT – Recruiting

Advanced Cell Technology is recruiting individuals with dry AMD and very poor vision for this Phase 1/2 safety and tolerability trial.  It will evaluate the effect of injecting retinal pigment epithelium (RPE) cells under the retina. These RPE cells were grown from human embryonic stem cell lines that have been maintained for years.  The purpose of the study is primarily to determine if the surgery is safe, if there are any negative side effects, if the injected cells can spread through the retina and if they are functional.

Preliminary data from the earlier groups being studied indicate that the technique is safe and well tolerated. They have been able to measure the development of these cells in the retina.  No safety issues have emerged.  Some participants report they feel their vision is better, though no improvement has been measured on standard eye charts. At least one participant has exhibited a marked improvement in vision.

At this point of the trial, participants are receiving a single injection of 200,000 cells.  All patients are being monitored for 12 months.  Study locations are in California, Florida, Massachusetts and Pennsylvania.  A parallel trial is underway for individuals with Stargardt’s macular degeneration, a form of MD that affects younger people.

For more information, visit ClinicalTrials.gov.

June 2014


Lucentis For Dry AMD

The clinical trial, Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (PREVENT) is a multicenter,double-masked Phase I/II study of individuals with dry macular degeneration who are at a high-risk for developing wet AMD. The study will determine whether quarterly injections of Ranibizumab (Lucentis) may prevent eyes with dry AMD from progressing to the wet form.

Individuals will be assigned randomly to two groups:  one just being observed for dry AMD as usual and one receiving quarterly injections of Lucentis.  The researchers will be tracking the progression of dry AMD in all participants.  The trial centers are in California and South Dakota.

For more information, visit ClinicalTrials.gov.

June 2014


Stem Cells – Bone Marrow – Recruiting

The SCOTS clinical trial (Stem Cell Ophthalmology Treatment Study) will evaluate the use of stem cells derived from the patients own bone marrow.  The research includes a comparison of different types of injections of the cells.  One will be the standard intravitreal injection into the eye.  Several other methods of injecting into the eye will be used and compared.  Routine intravenous injection will also be assessed. Patients will be followed with routine comprehensive eye examinations for 12 months.  Patients are being recruited in two locations, Margate, Florida and Dubai in the UAE.

For more information, visit ClinicalTrials.gov.

June 2014


Stem Cells – StemCells, Inc – Recruiting

The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to dry age-related macular degeneration.  This is accomplished with a single injection beneath the retina.  HuCNS-SC are human central nervous system stem cells.

HuCNS-SC cells are different from some of the other stem cell trials. They are purified human neural stem cells. In previous work, these cells were shown to survive a long time, holding out the possibility that a single injection could provide a lasting effect. Eight patients are in the first group. All subjects have dry AMD. Half of them received 200,000 cells and half received 1 million cells.  The study will recruit another 8 patients for the second cohort.  All of them will receive 1 million cells.

The clinical trial is taking place in multiple U.S. locations and is sponsored by StemCells, Inc.  For more information, visit ClinicalTrials.gov.

May 2014


Brimonidine For Dry AMD – Recruiting

This is a Phase 2 study to test the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration.  Patients will be randomized into two groups:  one to receive an implant that provides a sustained release of a drug that was shown to be neuroprotective; one to receive a sham implant with no drug.  It is a double-masked study, which means neither the doctor nor the patient will know which group the patient is placed.  It is taking place in two sites in Texas that will recruit 300 people to participate.  The sponsor is Allergan.

For more information, visit Clinical Trials.gov.

May 2014

LFG316 For Dry AMD – Recruiting

This Phase 2 study is a randomized clinical trial of a drug that targets the C5 complement pathway (part of our immune system).  It is designed to test the safety and efficacy of different doses of LFG316.  There are three arms in the study:  one group receiving a higher dose of the drug; one group receiving a lower dose of the drug; one group receiving a sham injection (no drug).  These are successive monthly injections for people with geographic atrophy (GA). It is taking place in multiple locations throughout the U.S. and is sponsored by Novartis.

For more information, visit ClinicalTrials.gov.

November 2014


Stem Cells – Bioheart – Recruiting

This is an open-label, non-randomized multi-center study using adipose stem cell (ASC) implantation. ASCs will be derived from the patient’s adipose or fat. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via needle injection into the eye.  The study in Florida will enroll up to 100 patients to determine the safety and efficacy of adipose derived stem cells or AdipoCellTM in patients with dry macular degeneration.  The study is sponsored by Bioheart.

For more information, visit ClinicalTrials.gov.

May 2014


Oracea Pill For Dry AMD- Recruiting 

This study will test the safety and effectiveness of an investigational drug called ORACEA® to determine if it can slow the progression of geographic atrophy in dry age-related macular degeneration.  The pill contains doxycycline, which helps prevent photoreceptor cell loss. Participants will be randomized into two groups – one to receive a daily pill of Oracea and one to receive a placebo pill.   The pill is self-administered every day for 24 months.  The study is underway at multiple sites across the U.S.

For more information, visit Clinical Trials.gov.

November 2014


Pills For Dry AMD-Acucela-Recruiting

The Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride is underway to study an oral medication for geographic atrophy (GA) in dry AMD.  Currently known as ACU-4429, the pill is being tested in several different dosages, to determine its safety and tolerability.

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Eye Drops For Dry AMD – Not Recruiting

Alcon Research is completing a study of an eye drop to treat geographic atrophy, an advanced form of dry macular degeneration.

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Sirolimus-Not Recruiting

Sirolimus helps prevent inflammation and may help treat geographic atrophy(GA), the advanced form of dry macular degeneration.  In this study, the drug is injected into the eye every three months.

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Copaxone (Glatiramer Acetate) – Not Recruiting

This small trial of 30 people with dry AMD involves a weekly vaccination with the drug Copaxone.  This is NOT an injection in the eye.

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Othera Eye Drops – Not Recruiting

This is a Phase II clinical trial of an eye drop, using 198 patients with geographic atrophy (GA). GA is the advanced form of dry macular degeneration in which an entire area of cell death occurs. Geographic atrophy is the greatest risk factor for advancing from dry AMD to wet AMD.

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Complement C5aR Inhibition – Not Recruiting

C5aR is a complement factor that has been found localized in drusen and on the edges of geographic atrophy.  Preclinical studies have suggested that blocking C5aR could be useful in stopping wet macular degeneration. One of the hopes we have in research is that we can find something that will stop dry AMD from advancing to wet AMD. For dry AMD, this drug is being studied to see if it will reduce drusen and the size of geographic atrophy.

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Fenretinide Pill – Terminated

In a Phase II clinical trial of the pill fenretinide,  for patients with dry macular degeneration and geographic atrophy(GA) has been completed with positive results.  The data showed that fenretinide slowed the growth of geographic atrophy lesions by 45% in the 300 mg dose. Followup at the 24 month point maintained this result.

Unfortunately, because of a change in manufacturing processes in the middle of this trial, the data cannot be accepted for review by the FDA.  Unless some investor is willing to fund a repeat of the clinical trial, this promising treatment will probably never come to market.

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Laser For Drusen – Trial Completed

Complications of Age-Related Macular Degeneration Prevention Trial (CAPT). This multi-site trial, coordinated by the University of Pennsylvania used low-intensity laser to treat drusen in people with dry AMD. The study has been completed but participants are still being followed.

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