Friday, November 22, 2013

Update on Current Clinical Trials

It is an exciting time in medicine and especially for Stargardt's sufferers and others with inherited retinal diseases. Here is a summary of current trials:

Phase I/IIa study of StarGen (Gene Therapy)
This study is being conducted by Oxford Biomedica at two sites, Oregon Health and Science University (US) and Institut de la Vision (France). Recruitment was suspended earlier this year to investigate impurities in the substance. The study will resume in about three months. 

Sub retinal injection of hESC into RPE (Stem Cells) 
The phase I trial being conducted by Advanced Cell Technology is continuing. The second cohort was recruited in July. There have been no further updates since the last press release. 

Stem Cell Ophthalmology Treatment Study SCOTS
This stem cell study is using cells derived from autologous (your own) bone marrow which is then injected into the retina. The study is looking at whether there is improvement in visual acuity and visual fields. It is not only looking at Stargardt's patients but also patients with optic nerve diseases and other retinal diseases. The study is being conducted by the Retinal Associates of South Florida (US). This will be an interesting study to monitor.

Safety and Tolerability of MA09-hRPE cells (Stem Cells)
This is another embryonic stem cell trial currently recruiting in Korea, conducted by CHA Bio and Diostech. The trial is similar to the ACT trial.

Saffron Supplementation and SD
Another study currently recruiting is looking at the effects of saffon supplementation on Stargardt's specifically. The study is being conducted at the Catholic University of the Sacred Heart in Italy. The study is a crossover design meaning that each participant will receive the placebo and treatment for a period of time. I have personally tried saffron and feel as though my sight improved so I am looking forward to the results of this study.

ProgSTAR Natural History Study
This study is funded by the Foundation Fighting Blindness and aims to investigate the disease further and also follow the progression of the disease. This information can then be used in future intervention trials. This is a multi centre trial across the US, UK and Germany. This would be a great study to participate in if you are local to one of the centres. 

Natural History of Eye Diseases Related to ABCA4 Mutations
Here is another study looking at disease progression in Stargardt's . It is being conducted by the National Eye Institute in Maryland (US). To participate you must be at least 12 years old and follow up is over five years. 

Novel Quantification Methods to Detect Progression in SD
This is another trial currently recruiting which is using a specific technique is learning more about the progression of Stargardt's. The trial is being conducted by the Kellogg Eye Centre in Michigan (US). This study is focusing on kids and teens (ages 5-18).

High Resolution Retinal Imaging Study
This study is looking at the use of an adaptive optics scanning laser opthalmoscope AOSLO to take pictures of the retina. The aim is then to analyse these pictures to better understand Stargardt's. This study is also being conducted by the National Eye Institute. 

Looking forward to seeing the results of all the trials.I will keep you all posted. 

10 comments:

  1. Thanks for the post! I know it is difficult to deal with eye disease. I watched my mom go through it, I know there is ways to help though.

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  2. Thanks for this I've been looking into eye disease in Fort Meyers, FL to help a friend out who has been having a lot of eye trouble and this gave me a lot of good insight.

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  3. I have optic nerve damage and I was just curious the other day as to the other eye diseases that are out there. Is there a knowledgeable optician that I can speak to in Fort Meyers, FL that can help me understand more about eye disease in general?
    | www.associatesineyecarefl.com

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  4. Hi Bryan,
    I'm in Australia so not sure about specialists in your area. Maybe try google or a facebook support group. Sometimes you need to shop around until you get answers.

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  5. Hi Chrissy. I have macular dystrophy and I'm enrolled to participate in SCOTS clinical trial in a few months. I'm not sure if I am going ahead with it though because, unlike other trials, they charge participants US$20,000 for the procedure. There is a lot of talk about it over on investorstemcells wgether it is scam or not. Part of me wants to go ahead with it, but of course there are no guarantees.

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    1. Mark, I'm not sure if you're still monitoring this blog, but I have completed SCOTS (for inherited macular degeneration) in August '15 , and went from 20/400 in both eyes to 20/30 in one eye and 20/40 in the other in a few months. It's no joke, and it's been verified by my retinal specialist at Vanderbilt Medical Center. There are U.S. Federal funding blockages for the study, which is why it is privately funded and therefore not covered for participants. It's Federally Approved as safe. Chrissy, I'd be glad to dialogue with you as well. Doug from Nashville

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    2. Doug - my husband is scheduled for SCOTS trearment for March 1, 2016. I would love to hear more about your experience.

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    3. Doug - my husband is scheduled for SCOTS trearment for March 1, 2016. I would love to hear more about your experience.

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  6. Hi Mark,
    That's a ridiculous amount of money! Trial participation shouldn't be paid for by patients! I'd be very careful. I'll have a look into it and see what I can find out. :)

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