Mass Eye & Ear MGD Trial

[Gretchen]

They will give you the drug if you are not in the trial

Hi Sazy -

They will give you the drug if you are a good candidate even if you do not take part in the trial. However, you have to go to Boston for the initial as well as all follow-up exams.

HTH,
Gretchen

[odydnas]

I am very interested in this thread.

Thanks Gretchen for posting this info.

Eli and Mike, I am patiently waiting to hear your results. Please keep us updated!!!

[Eli]

Hi guys,
I went to Mass Eye and Ear yesterday for my initial trial screening.
Two of Dr. Reza Dana's assistants performed all of the usual tests including: visual acuity, intraocular pressure, corneal staining with both flourescein and lissamine green dyes and finally both an un-anethetized schirmer's and then one with proparacaine. They also had me fill out a questionaire where you rate your discomfort and asses the impact dry eye has on various daily tasks. The results were that I have very minimal corneal staining in the left eye, none in the right and a TBUT of between 6-8 seconds, which is great because it was 0 seconds two years ago. Oddly, the schirmer scores were quite a bit lower than they were two years prior, although they still fall within the normal range. The expressed meibum from my eyelids is still quite viscous unfortunately, but at least the glands are still patent and working.
Due to my minimal corneal staining, I may not be able to participate in the trial, however, I was informed that Dr. Dana has been prescribing the new medication to suitable patients outside the study. My understanding is that the drops use Anakinra compounded into Refresh Tears or Liquigel in either 2.5% or 5% concentrations. See here:http://en.wikipedia.org/wiki/Anakinra
This is the same agent used in Kineret, the arthritis medication. I was told that so far no side effects have been seen and that the treatment has been quite efficacious in reducing signs and symptoms of MGD in some patients.
I look forward to meeting with Dr. Dana next week and will keep you all posted.

[Gretchen]

Great Info!

Hi Eli -

Thank you for the detailed update on your visit. And good news about your TBUTs and minimal corneal staining! I was also told that Dr Dana would administer this medication if you were a suitable candidate outside of the trial.

Keep us updated. This sounds very promising.
Gretchen

[sazy123]

Gretchen, how many follow up appointments are there?

Thanks

[Gretchen]

Hi Sazy -

There are as many follow-up appointments as they Dr Dana thinks that you need - so it is variable.

Another thing that they told me is that they are only compounding the eye drops there and that they only keep for 28 days so that they would have to ship them to you if you needed a refill and were not coming in that month.

HTH,
Gretchen

[Eli]

Rejected!

Hey all,

Here's the latest update from clinical trial land. Due to insufficient corneal staining I do not qualify for the trial. Frankly, given the severity of my symptoms I am quite surprised that the flourescein didn't reveal something more significant. One of the researchers joked: "Good news for you, bad news for the trial." Fair enough. Dr. Dana, the doctor running the study, later pointed out that it is not uncommon for patients to have symptoms way out of proportion to the clinical findings. In light of my discomfort, he agreed to prescribe the Kineret drops anyway, suggesting the 2.5% version which costs $125 for a 28 day supply. You use them 3 times per day or TID in doctor speak. The drops are custom compounded at Mass Eye and Ear only and need to be refrigerated. The pharmacy can overnight ship them on ice though if you live out of town.
Dr. Dana says this new treatment seems very promising and has not observed any side-effects after prescribing it for over a year. He will want to see you again 1 month after you start the treatment. I don't know about after that.
I should point out though that an appointment at Mass Eye & Ear will run you
$300. I almost had a heart attack when I went to check out and they told me as I don't have insurance. Still, if these Kineret drops are effective it will have been money well spent.

[odydnas]

Eli, Thanks for updating! I am glad you were able to get the Kineret drops anyway and I really hope they help. Do you know how soon you are supposed to feel a difference?

Please keep us updated!

Thanks!

[Gretchen]

Eli -

Thanks so much for the informative post. Keep us updated on how you progress. It seems that they are also trying this drug for corneal neovascularization. Did he discuss with you the mechanism whereby the medicine is supposed to work?

Thanks,
Gretchen

[Eli]

Odydnas- You know, I forgot to ask Dr. Dana how long it takes for the drug to have an effect. Kind of silly on my part. I was more concerned with finding out IF it worked and what side effects were being seen. Turns out there have been none so far.

Gretchen- Dr. Dana didn't explain the mechanism of action but one of his research associates sort of did later. As you may know, Kineret is FDA approved to treat rheumatoid arthritis. Of course in this application it is used systemically and not topically. Here is a blurb from the info sheet they gave me:

"A specific protein called interleukin-1 (IL-1) is produced by the body when part of it becomes inflamed and the immune system responds. Recent data suggest that the IL-1 plays and important role in the regulation of inflammation in the corneal and eye surface diseases. Kineret is a synthetic form of a protein that naturally occurs in the body called interleukin-1 receptor antagonist (IL-1Ra). Kineret can help manage excess levels of IL-1 in the body...... The purpose of the off-label use of topical Kineret which is given as a custom made drop applied to the surface of the eye, is to treat your corneal or ocular surface inflammation."

Wikipedia had the followingto offer, which is similar:

Anakinra is an interleukin-1 (IL-1) receptor antagonist. Anakinra blocks the biologic activity of naturally occurring IL-1, including inflammation and cartilage degradation associated with rheumatoid arthritis, by competitively inhibiting the binding of IL-1 to the Interleukin-1 type receptor, which is expressed in many tissues and organs. IL-1 is produced in response to inflammatory stimuli and mediates various physiologic responses, including inflammatory and immunologic reactions.

[Gretchen]

Eli -

Thanks for the info. This is really interesting because IL-1 is the protein that induces a lot of nasty stuff - angiogenesis, cytokines...

Regards and keep us updated.
Gretchen

[Gretchen]

Anything Yet?

Hi Eli -

Just wondering if you are seeing anything yet with the Kineret - benefit or otherwise?

Thanks,
Gretchen

[Eli]

Gretchen-
No epic results yet I'm afraid. However, my eyes do seem to be somewhat whiter than usual. Also, I've had some yellow bumps begin to appear on my lid margins. While this may sound like a negative finding, I like to think the glands are actually trying to regain normal function and are producing more oil. This phenomena was frequent back when I was taking Oracea (oral doxycycline). I'm not even a full week into the treatment though, so I guess it would be a little early to see huge improvement. I will keep you posted.

[Gretchen]

Any updates?

Hi Eli -

How are you doing? Any updates?

Regards,
Gretchen

[odydnas]

Hi Eli,

Any updates on the Kineret?

Thanks!