AM-101 Clinical Trial — Participants Updates and Discussion

@earsnohappy thanks for the clarification. stress could make sense, there is no wavy vision in either eye when singled out. I don't see how seeing a less advanced doctor would help, but I guess the only thing it could hurt is my wallet.
 
@Mikey Cliff

If you're not having those symptoms in one eye, then it's probably not a CSR then. You'd know immediately the moment you look at a grid. One eye would be fine and the eye with the CSR would be wavy. That's one of the tell tails signs of a CSR is wavy lines caused by swelling of the retina.

That's the extent of my knowledge on what I thought might be what you're experiencing.

I hope your condition improves!
 
i got floaters...and i get the wavy vision too from time to time. Have you had lasik in the past? I have...i don't know if there is any correlation between the two. My floaters bug me sometimes as do the waviness....when i get the waviness its almost a feeling of wet eyes.....who know.s.
 
Congrats Sergerold.

What is the status of your Tinnitus rating going into the AM101 Trial? That is on a scale of 1-10, 10 being worse where do you average and how does it change day over day? Also, does it affect you emotionally enough to cause stress and axiety?

All this is important to know for us going into the trial. If you have a moment, we would love to hear about this before you go in for your first injection. Also, can you provide some detail on your trial schedule and if you will be able to keep us posted regularly? I would like to follow you on this thread as i am sure so many others will. Also, please be sure to make a selection from the selections at the top of this thread when the time comes for all of our benefits.

Thank you.

Hi,

Sorry for the delay in getting back to you.

I'd say my tinnitus is around a 3 - 4. It gets worse at night. Emotions seem to have little effect.

I'm due to be randomised in two weeks (there was a delay due to GPs being slow). I believe that this is when I will receive the injections.

I will of course keep everyone update.

Thanks
 
Second day of second (real) round of injections.

Had a headache for a few hours during the night after the first injection yesterday. T was louder this morning and all today. Increase not enough for me to bail given the chance it might get softer.
 
Hello all,

I've been following this forum since about September and I am now 23 days into the second round of AM-101 treatments. I wanted to wait to post so I could give a more complete description of my experience. Short story: If I rated my tinnitus before my second round of injections (90 days after the first round) I'd be somewhere between No Change or Uncertain and Got Slightly Worse. If I rated my tinnitus today (23 days after the final injection of the second round), I'd be between Got Slightly Worse and Got Moderately Worse.

I first noticed my tinnitus toward the beginning of 9/2014. The causes of my tinnitus could be an ear infection that I had a couple weeks earlier or barotrauma that I also experienced a couple weeks earlier. I also have hypothyroidism, and I've read that fluctuations in thyroid hormone can cause tinnitus. So pinpointing the cause of my tinnitus is not clear cut.

My first injection was on 10/27/2014. As others may have described, the procedure is not the most pleasant thing you will do during that day, but it's not really that bad. I had slight discomfort with the application of the numbing agent, and a little dizziness when the numbing agent was sucked out. That passed within 30 seconds. During the injection, you feel pressure and a slight poke then you can feel the cold fluid fill your ear. I also heard some popping as the air in my ear was being displaced by the fluid. There was a feeling of fullness in both ears and my hearing was muffled. My tinnitus was slightly louder after the first injection. The second injection was similar to the first, with an increase in tinnitus loudness. After the third injection, my tinnitus was much louder.

A week after the third injection, my tinnitus was beginning to return to pre-procedure levels but it took a couple more weeks to get back to pre-procedure levels. So the result for me after the first procedure was that my tinnitus was unchanged to a touch worse. I was convinced by this point that I received the placebo, so I was anxious to see what would happen during the second round when I was guaranteed to get the active drug.

My second round of injections was from 1/26 to 1/28/2015. Immediately following the injections, my tinnitus increased in volume, but to a lesser extent than it did the first round of injections. It took much longer for the fluid to drain from my ears this time around. I had felt my ears popping up to around 2/12/2015. At two weeks from the third injection, my tinnitus has been more prominent than it was before the procedure on 1/26. Previously, I had been able to ignore the ringing during ~70% of my waking activities, but I am noticing it much more often now due to increased volume. Thankfully, the volume started to decrease around 2/14. It's now 2/20 and it's still louder and more noticeable that it was before the second procedure. My hope is that it will at least return to pre-procedure levels.

Participating in a clinical trial is a risk, but I did have the expectation that AM-101 would help me. So it has been difficult to reconcile my expectation with my results as they currently stand. Coping with this reality has been a real challenge over the last four months.

I'll plan to update at the 90 day mark.
 
Hello everyone,

I have been visiting this forum frequently over the past few weeks and I am finally registering only because I think I owe it to you all to share my experience with AM-101.

I Have Noise-Induced Tinnitus
My tinnitus occurred on the night of January 15th, 2015. I was listening to my Apple iPhone headphones at maximum level for about 15 minutes, before finally removing them to go to sleep. As soon as I removed the headphones I recognized the ringing. Two days later I went to the emergency room to figure out what was going on. The doctor had no clue how to resolve the situation and the ENT Specialist he referred me to had nothing to say other than wait it out and avoid loud noises. Not accepting the ENT's recommendation, I found myself obsessively searching through the web for more information about tinnitus and finally stumbled across this forum where I've read endless stories, some positive, some negative, all helpful. I was blessed to have found the AM-101 thread and immediately submitted my info on Auris' website. That same day I was contacted by a participating clinic.

It's worth noting that I have always used my headphones at max volume and never, ever experienced ear ringing. So even noise-induced tinnitus can strike out of no where.

My Tinnitus Level & Feelings Towards It
I would describe my tinnitus as faint. I can hear it when noises are around only when I make a conscious decision to do so. Before receiving the AM-101 injections, I could not hear it at all when taking a shower. And of course, in quiet environments, it's most noticeable. The first two weeks of having it I was really down and depressed but I got over that pretty quickly and I would credit that to being a deeply spiritual person and I have a really supportive social circle. It's merely an annoyance now... even the thought of having it forever doesn't really bother me. I think what also helps to know is that there is so much research and I am extremely confident in there being a treatment found very soon. Interestingly, the thought of my tinnitus being my body's rather innocent reaction to my abuse of it has been comforting--it's a weird perspective but for some reason it makes me less anxious.

AM-101 Experience
2/19 was my first round of injection (both ears). Ears were numbed, placebo or drug was inserted, no pain. After the first round the only difference was that my right ear tinnitus increased for the night--the following morning when I woke up for my second round of injections, it was back to normal... I want to say that my tinnitus on both ears decreased that morning but I am not entirely sure. The 20th was my second round and since then both my ears have been muffled and in pain and my right ear tinnitus is back up again... to be honest, I can't even say if the tinnitus on the left is completely gone or just being drowned out by the extremely loud right ear tinnitus. I believe the pain is due to excess liquid. Using the squeeze nose and blow technique has help relieve muffled feeling and pain.

This coming Monday I am going in for my 3rd injections. I will keep you all updated.

AM-101 & Chronic Tinnitus Suffers
Just want to say I asked my doctor who administered me AM-101 (possibly placebo) a host of questions. One was regarding its efficacy with chronic sufferers. Not sure if she is part of Auris' research team, actually, I doubt she is, but her opinion was that the 3 months requirement did not have any scientific merit. Auris is confident the drug can work on chronic sufferers but they want to attack the acute stage first just to play it safe. So I think there's hope for even chronic sufferers if this drug is proven effective.

Just A Positive Note

Just as tinnitus is subjective, so is our feeling towards it. Those of us who are suffering I think it helps to just develop a positive view toward your tinnitus. For the very short period I've had it, I went from breaking down in tears to the thought of having it forever, to eventually just looking at tinnitus as merely an innocent response that I ought to welcome. I've convinced myself that the sound is soothing me and as a result, the sound of it has actually been able to put me to sleep. I avoid the white noise now and welcome the tinnitus.

For those of us who are less controlling of their feeling towards it, just know this there is A LOT of attention out there on tinnitus research. I am in my early 20s and all of my friends have experienced short bouts of it due to headphone usage. Investors are aware of the increased headphone use of my generation and investment in tinnitus is financially promising. I am even preparing for investment in companies conducting research. So if anything should give you comfort, it should be knowing that research on tinnitus is exploding right now.

I have faith that we won't have to live with this annoyance for long.
 
Thank you for your post. A lot of hopeful information in there. People including myself have/ had no idea this existed. If they only knew they'd treat their ears better. Thanks for your positive outlook.
Anthony
 
Hi all,
Reporting in after reading the last two posistive posts, i think i am probabaly the furthest along with Am 101 now waiting for 4th set of injections in two weeks i too had a little wobble after 2 nd set of injections and i know a guy at the same point as me on the trial never proceeded with the third set of injections but my 3rd set of injections had truly breathtaking results in weeks 1 to 7 with my t level at its lowest since onset and my ability to recover and manage my T after a spike shortening in time , having good and bad days now but most importantly the bad days are not dragging me down i am coping and getting on with things, I honestly can't wait for next round of treatment,
And can not honestly believe i nearly opted out! Just to clear a few of the myths
  • Totally painless procedure uncomfortable but not painful
  • Fullness last a few days at most and does cause a little spike
  • I did get all my costs refunded for fuel and parking
  • As i am aware you will never know if you had am 101 or placebo at stage 1
Hope this helps any floaters
 
Hi all,
Reporting in after reading the last two posistive posts, i think i am probabaly the furthest along with Am 101 now waiting for 4th set of injections in two weeks i too had a little wobble after 2 nd set of injections and i know a guy at the same point as me on the trial never proceeded with the third set of injections but my 3rd set of injections had truly breathtaking results in weeks 1 to 7 with my t level at its lowest since onset and my ability to recover and manage my T after a spike shortening in time , having good and bad days now but most importantly the bad days are not dragging me down i am coping and getting on with things, I honestly can't wait for next round of treatment,
And can not honestly believe i nearly opted out! Just to clear a few of the myths
  • Totally painless procedure uncomfortable but not painful
  • Fullness last a few days at most and does cause a little spike
  • I did get all my costs refunded for fuel and parking
  • As i am aware you will never know if you had am 101 or placebo at stage 1
Hope this helps any floaters

@Matt h do you mind filling in the below?

General Information
  • Date of T Onset: 10/10/2013
  • Cause of T (if known):
1st set of injections
  • Date of First Injections:
  • Do you suspect placebo or AM-101:
  • Loudness (on a scale of 1-10) prior to the first set of injections:
  • Annoyance (on a scale of 1-10) prior to the first set of injections:

  • Loudness (on a scale of 1-10) at the end of the first injection cycle:
  • Annoyance (on a scale of 1-10) at the end of the first injection cycle:
2nd set of injections
  • Date of Second Injections:
  • Loudness (on a scale of 1-10) prior to the second set of injections:
  • Annoyance (on a scale of 1-10) prior to the second set of injections:

  • Loudness (on a scale of 1-10) at the end of the second injection cycle:
  • Annoyance (on a scale of 1-10) at the end of the second injection cycle:
3rd set of injections
  • Date of Third Injections:
  • Loudness (on a scale of 1-10) prior to the third set of injections:
  • Annoyance (on a scale of 1-10) prior to the third set of injections:

  • Loudness (on a scale of 1-10) at the end of the third injection cycle:
  • Annoyance (on a scale of 1-10) at the end of the third injection cycle:
 
Update after waking up this morning!

So after my first round of injections I expressed that I couldn't tell if tinnitus on my right ear was completely gone or if my right ear tinnitus was just so loud that it drowned out the left's tinnitus. I can say with about 75% certainty that it's the former. There's two reasons why:

1) According to my the doctor that administered me AM-101 (or placebo) my middle ear on my right side is much shorter than my left's middle ear. She brought this to my attention after I told her that it has been giving me more trouble during the injections. Additionally, one morning I woke up and my right ear was COMPLETELY crusted... as if it spit everything the doctor injected right back out. Makes me wonder if it really had the opportunity to absorb the drug.

2) With my ears uncovered I can ONLY hear tinnitus on my right ear now... even when I'm in quiet environment. Prior to injections I heard tinnitus on both sides or it felt like straight up head noise. However, when I cover my ears I am not sure if it's both ears or not. I think that the right ear produces a head noise so loud that I mistake it for coming from both sides when I cover my ears.

Hope this is useful to you all!
 
Please keep the thread to constructive questions and answers.

Since my second round of injections I experienced a week long spike, then a reduction in tinnitus intrusiveness. The volume between ears is no longer the same, the right ear has gone down more than the left. So far, a positive response.
 
Monday is my 30 day checkup.

At onset, loudness was a 7 or 8
After first round, it was a 5
30 days post 2nd round injection, it's a 3.

Not sure I'd call that a failure @Carlos Galiano ... On what experience do you make this bold claim? You haven't been here long enough to know and unless I'm mistaken, you aren't on the trial. So, perhaps you're a rogue researcher from Auris that is trying to blow the whistle?

I tire of these assertions from people that haven't gone through the trial.
 
IMO it just validates that tinnitus is subjective and people's perception can change from day to day.

My tinnitus is screaming right now. When I got up it was screaming, when I went for a bike ride it was OK because I was focused on the traffic, other riders, what was going on around me. When I got home I went for a short drive to the shopping centre and my tinnitus was screaming in the car like it always does. Tomorrow my tinnitus might be screaming or it might be OK who knows!

What I do know is that our perception changes with our environment.

What I do know is that if you monitor your tinnitus it will most likely seem worse. And this will be the case even if you have been taking the placebo.

When somebody comes up with a drug or treatment that stops tinnitus in its tracks we will all know about it.
 
What I have noticed is that some people have voted that their T is better post injections and then when having a look at their latest posts they are still posting that they have very loud T and how to cope or are habituating or taking meds or asking for different meds....
How is this then that the am 101 has improved their T?
@locoyeti posted that his T is moderately better post injections but he also took trobalt and swears that the trobalt has done this for him.
@tomm too has posted a lot better but he has also taken Trobalt and was thinking of autifony too.
So I am left extremely concerned at these post votes.
Can anyone explain this to me please....
thanks
 
Hello everyone!
This is my final post regarding my current AM 101 trial.
Today is the final day of this trial. I had my follow up appointment just a few hours ago. The final results on how everything went were all positive.

First. I would like to clarify that I still don't know if I recieved the actual drug or not.
I wont know until the whole study is over. I estimate they wont tell me for at least a year and a half as this research center is still recruiting participants (Godspeed to them!)

Now, on to buisness. The first part of the follow up appt was a meeting with the study coordinater. She informed me that I am elligable to participate in a follow up study. This study is virtually the same one as I just did. However, there is no more placebo in the mix. Its the real deal. Better yet I can choose to repeat the processes 3 times. Thats 3 extra chances for improvement.

Afterwards was the final hearing test and tinnitus matching test. My hearing test showed 0% of any hearing loss.
And for what everyone wants to hear the tinnitus matching test showed a great reduction in db levels.
My first hearing test that I did at the beggining of the study showed I had an estimated 57db~60db loudness of tinnitus inside my head (This is in both the ears)
Todays testing showed that my tinnitus loudness was an estimated 35db~37db..
This is a total of a 25db reduction in my levels.
This is a huge improvement. Only times I ever notice my tinnitus anymore are when I either plug both my ears to listen for it or late at night in my quiet room.
So as you can see from my perspective, this AM 101 serum has shown to be effective up to a 25db decrease in tinnitus loudness.
I am very pleased with the results.

The final appointment was with the doctor himself. He said my ears have no visual scarring on the ear drum and my nerves linking my balance to my eyes were normal. (They check your eye movements)

I am choosing to do another trial seeing as I have had a positive outcome in this last one. I recieve 3 new injections of the LEGIT drug in 2 weeks time.
I am certianly going to update this thread on how its going and how it turns out from here.

Here is hoping I can turn my 35db tinnitus into 15db or 5db or HOPEFULLY 0..


Time will tell.
 

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