by Dan Roberts
November 2003
(Updated April 5, 2004)

A Connecticut ophthalmologist has been reporting success from a deceptively simple treatment on patients with Stargardt's disease and other non-neovascular forms of retinal disease. Dr. Gerard Michael Nolan has performed the treatment, called ECHO therapy, for nearly three years on more than 200 patients at the Nolan Eye Clinic in Farmington, Connecticut, and he is now working to locate support for FDA-approved clinical trials.

Dr. Nolan, a diplomat of the American Board of Ophthalmology, is a graduate of Georgetown Medical School and completed his residency at Cornell Medical Center in New York. In a discussion with people from the MD Support email support group in early October 2003, he said, "In the course of my ophthalmic practice, I discovered that a topical drop of dilute echothiophate (ECHO) can restore lost visual acuity in some cases of chronic retinal disease. ECHO appeared to increase the capability of the few surviving neurons, endowing this reduced population with an enhanced stimulus potential. These effects need to be studied in multi-center controlled clinical trials."

ECHO was used for 40 years for the treatment of glaucoma, but it has been replaced by better drugs for that purpose. Since it is no longer commercially available, Dr. Nolan has obtained a pharmaceutical patent and is now seeking a company to manufacture it. He has also filed an application for an FDA "new drug investigation," and contact is being made with potential research groups and funding resources. The FDA's approval is necessary, because, even though Dr. Nolan's use of diluted echothiophate is considered an off label usage of a legally marketed medication, the drug has not yet been reviewed or approved for treatment of retinal disease.

According to Dr. Nolan, the therapeutic benefits of ECHO may have previously remained hidden as the result of two key factors:

1. The dosage of the drug must be much lower than what was prescribed for glaucoma (one drop in one eye every four days, plus a drop in the other eye four days later); and

2. For best absorption, the drops must be administered before a good night's sleep.

Several people from the MD Support group are among the many who have traveled to Connecticut for ECHO therapy. Most have returned with accounts of significant and measurable improvement in their vision. In response to the positive reports of these patients, Dr. Nolan said, "I have been encouraged every step of the way by the equally important discovery of caring and committed folks such as the MD Support group. I appreciate your key role in this quest and thank you for your confidence and support."

Dr. Nolan is excited about eventually turning his work over to clinical trials. He said, "I honestly feel like I'm watching my child head off to the first day of school. I'm proud and hopeful, but whatever may happen, I'll be satisfied with the outcome and will have no regrets about my time and heart invested in this journey."

The cost of the therapy is $500, and a bottle of echothiophate costs $35. Charging for treatment in advance of clinical trials is often frowned upon in medical circles. It is, however, neither illegal nor unprecedented. Patients must also bear the expense of travel to the Nolan Eye Clinic for treatment, and then continue self-administering the eye drops at home.

MD Support will continue to follow Dr. Nolan's progress with this effort, and we will report further developments on this site as information becomes available.

To learn more about ECHO therapy, read the transcript of the MD Support community's discussion with Dr. Nolan at www.mdsupport.org/clinic/nolansession.html.

To read the continuing personal accounts of patients from the MD Support community who are undergoing the treatment, see "ECHO Therapy" in the MD Support Treatment Archives.

Dr. Nolan's yet-unpublished paper on ECHO therapy may be downloaded from www.mcglamry.net/images/StargardtsCaseStudy.doc.

UPDATE:

In a phone conversation with Dr. Gerrard Nolan by phone on April 5, 2004, this writer was given the following information about progress toward clinical trials for ECHO therapy:

1. It is likely that the FDA will meet with Dr. Nolan during the month of April 2004 to consider approval for trials.

2. It is possible, due to the work already accomplished, that the trial may be able to begin at Phase III (the final stage). This would greatly diminish the length of time and provide quicker .

3. The trial may need only 24 subjects, and recruitment will begin as soon as approval is attained.

4. A major university hospital is considering heading the research, and the relatively minimal required funding necessary may be provided by the FDA itself.

5. Medicare and Medicaid is reimbursing for the therapy even at this pre-trial level, since echothiophate has already been FDA-approved (for glaucoma therapy), and the cost of the appointment (about $500) is viewed as testing and evaluation.

Dr. Nolan welcomes the most stringent testing of his discovery, since that is the only way to verify beyond doubt that ECHO therapy either does or doesn't work as well as it appears.