Clinical Trials For Wet 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.

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.


Fovista – Recruiting

The objectives of this Phase 3 study are to evaluate the safety and efficacy of intravitreal administration of FovistaTM administered in combination with Lucentis®,  compared to Lucentis® alone in subjects with wet age-related macular degeneration (AMD).  Fovista, also known as E10030, is injected into the eye and affects not only VEGF but also PDGF. Both are growth factors associated with wet AMD.  Current treatments only affect VEGF alone.  Participants will be randomly assigned to one of two groups and the study is double masked.  It is sponsored by Ophthotech and is taking place at multiple sites throughout the U.S..

For more information, visit ClinicalTrials.gov.

June 2014


Squalamine Eye Drops – Not Recruiting

The purpose of this Phase II study is to evaluate the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD).  The eye drops are administered by the patient once a day.
There are two arms of the study.  One group uses the Squalamine eye drops and the other group is using a placebo eye drops.  It is a double masked study, so neither the doctor nor the patient knows which drop they are given.  The research is sponsored by Ohr Pharmaceutical and taking place in multiple U.S. locations.  Although it is not recruiting now, if the data from this trial is successful, they will begin recruiting for a larger Phase III clinical trial.

For more information, visit ClinicalTrials.gov.

June 2014


X-82 Pill – Recruiting

The objective of this Phase I/II study is to evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD). This is an open label, dose escalation trial of the pill, X-82, along with rescue therapy with Lucentis.  All patients will be treated with X-82 over a six month period. The dose of X-82 will be steadily increased over time.  Standard therapy with Lucentis will be given as needed.  The study takes place at multiple locations in the U.S. and is sponsored by Xcovery Vision, LLC.

For more information, visit ClinicalTrials.gov.

June 2014


Proton Beam Radiation – Recruiting

The purpose of this Phase I/II study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.  Anti-VEGF therapy is the current standard treatment for wet macular degeneration and consists of injections of Lucentis, Avastin or Eylea. This is a double masked study.  Avastin is the anti-VEGF treatment being used here. Participants will be randomly assigned to one of three groups:  Radiation at a higher dose with anti-VEGF therapy, radiation at a lower dose with anti-VEGF therapy or sham radiation with anti-VEGF therapy.  Individuals must be newly diagnosed or have only received on anti-VEGF treatment prior to the study.

The research is being conducted by the University of California, in Davis and San Francisco.

For more information, visit ClinicalTrials.gov.

June 2014


ISONEP – Recruiting

The purpose of this Phase 2 study is to determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis, Avastin or Eylea.  The experimental treatment is for individuals with wet Age-related Macular Degeneration (AMD) and who have already received a minimum of 3 injections of Lucentis or Avastin within the past year.  Patients in the study will be assigned to one of four groups, to receive  iSONEP alone or at different dosages in combination with Lucentis, Avastin or Eylea.  iSONEP may have the ability to achieve better visual outcomes than Lucentis, Avastin or Eylea, particularly in those subjects who do not demonstrate a robust response to Lucentis, Avastin or Eylea after several monthly injections. Further, the combination of Lucentis, Avastin or Eylea and iSONEP may be additive or synergistic. By inhibiting the multiple mechanisms that contribute to exudative-AMD-related vision loss, better visual outcomes may be possible than with Lucentis, Avastin or Eylea alone.

This clinical trial is taking place in 48 centers around the U.S., which are listed atClinicalTrials.gov. It is sponsored by Lpath, Inc. and Pfizer.

June 2014


PAN-90806 – Recruiting

The objective of this PHASE I study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD). Each of the three groups will receive eye drops of a different dose, to be used by the patient over two months.  This is only for newly diagnosed patients who have not received any other treatment for wet AMD.  The sponsor is PanOptica, Inc. and the study takes place only in St. Louis.

For more information, visit ClinicalTrials.gov.

June 2014


RO6867461-Recruiting

This Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration. Patients will receive a single intravitreal dose of RO6867461 and will be followed for 12 weeks.  All patients in the study will receive the drug.  Taking place in multiple centers in the U.S., the trial is sponsored by Hoffmann-La Roche.

For more information, visit ClinicalTrials.gov.

June 2014


REGN2176-3 – Recruiting

The primary objective of this Phase I study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (wet AMD).  Four different dosages will be tested over 24 weeks.  Regeneron is the sponsor and the trial is taking place in multiple centers in the U.S.

For more information, visit ClinicalTrials.gov.

June 2014


Ophthotech-Not Recruiting

This injectable therapy (E10030) is currently in a Phase 2b trial with 445 patients with wet macular degeneration.  It compares outcomes between patient groups receiving standard Lucentis treatment and those receiving Lucentis and E10030.  Lucentis blocks the substance called VEGF, which promotes the growth of blood vessels.  E10030 blocks a different substance, PDGF, that seems to contribute to wet AMD as well. The goal is to show that the combined therapy provides better results.  Results of the trial will be released in the first half of 2012.  For more information, visit Clinical Trials.gov or Ophthotech.


REDD14NP – Recruiting

REDD14NP– Quark
This Phase I study is recruiting patients with wet macular degeneration to receive a single injection of a drug designed to interfere with a gene that seems to be active in creating AMD.

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Sirolimus (Rapamycin) – Not Recruiting

Sirolimus (Rapamycin)

This is a randomized, multi-center study and is taking place throughout the United States. Sirolimus is designed to stop the growth of blood vessels in the macula.

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ATG003 Eye Drops – Recruiting

ATG003 Eye Drops
This study is investigating the use of an eye drop in patients who are already getting Lucentis or Avastin.

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CABERNET Radiation Implant-Phase 3 Results

CABERNET – Strontium-90 Beta Radiation Implant Trial

Results are now available for this Phase III trial.  After 2 years, the study could not show epiretinal brachytherapy to be “non-inferior” to Lucentis.  Noninferiority was the primary endpoint for the clinical trial.  Previous research had led to the hope that radiation treatment could be used with Lucentis to reduce the number of injections that were needed.  More research will be conducted, but these results are a set-back for this experimental treatment.

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Radiation Therapy – Recruiting

Enrollment is underway for a clinical trial for the treatment of wet age-related macular degeneration (AMD). The trial is sponsored by Theragenics Corporation® and will investigate the safety and ability of using the TheraSightTM Ocular Brachytherapy System to treat wet AMD.

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COBALT Combination Therapy – Not Recruiting

COBALT – Bevasiranib & Lucentis Combination Therapy
A Phase III clinical trial is no longer recruiting patients to participate in a comparison study between Lucentis and Bevasiranib.  Opko Health, Inc.

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Potentia Pharmaceuticals – Recruiting

This Phase I study (called ASap) will provide safety and tolerability information on the complement inhibitor (POT-4) injected into the eyes of patients with wet AMD. Earlier animal studies showed no toxicity even when injected at high concentrations. Participants received a single injection of the drug, with some patients receiving higher doses than others. This is a one year study, but information from the early data is being released.

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Completed Clinical Trials

Here are some of the clinical trials that have been completed recently:

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