Clinical Trial Goal
To find out if d-MAPPS is safe and works well to treat chronic GVHD of the eye
You may be able to join this trial if you:
- Are 18 years old or older
- Have cGVHD of the eye
- Do not have any of the following:
- Lupus
- Rheumatoid arthritis
- Scleroderma
- Have not been treated with topical tacrolimus. Your doctor can tell you this
- Do not use topical steroids more that 2 times each day
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
d-MAPPS are eye drops that suppress the immune response in the eyes and promote tissue repair.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – d-MAPPS
- Group 2 – Placebo
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get:
- d-MAPPS - Group 1 only – Given as eye drops 4 times each day
- Placebo - Group 2 only - Given as eye drops with no medicine in them 4 times each day
You may continue treatment for 3 months. You will take surveys and be scored by doctors on a scale to see how well the treatment is working. The clinical trial doctors will check your health for up to 4 months.
The Food and Drug Administration (FDA) has not yet approved d-MAPPS for the treatment of cGVHD of the eye.
Locations
Sponsors
lead: Regenerative Ocular Immunobiologics LLC
