Age-Related Macular Degeneration (ARMD) Clinical Trials

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Randomized, Prospective, Vehicle-Controlled, Phase I/II Clinical Trial to Evaluate the Safety and Feasibility of a Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema

Who is this study for? Patients with recurrent cystoid macular edema
What treatments are being studied? Dexamethasone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The main aim of the pilot study is to determine preliminary estimates of the safety, tolerability, and comfort of a dexamethasone-eluting therapeutic contact lens drug delivery system (TCL-DDS) for the treatment of recurrent cystoid macular edema. Secondarily, feasibility of the TCL-DDS system will be investigated. 1. Safety: To establish that a topical dexamethasone delivery system has an acceptable safety profile by determining the incidence and severity of ocular adverse events, as identified by eye examination through day 28 following treatment initiation. 2. Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS. 3. Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Adults between the ages of 18 and 85 Willingness to participate in the study and provide informed consent For Phase A, patients who only respond to anti-inflammatory drops (not at the intravitreal steroid injection phase of care yet).

• For Phase B, patients who only respond to steroid intravitreal injections (anti-inflammatory drops are no longer therapeutically working for these patients).

• Corneal thickness between 480 and 620 µm in the study eye by anterior segment OCT.

• Diagnosis of cystoid macular edema in the study eye defined as macular edema involving the center of the macula (fovea) with one or more of the following OCT characteristics: retinal cysts, retinal thickening, and/ or subretinal fluid.

• Visual acuity between 20/400 and 20/25 in the study eye, measured by pinhole VA.

• Retinal thickness above 300 µm as measured by OCT in the 1mm central macular subfield of the study eye at screening as determined by the investigator History of positive response to topical or intraocular steroid treatment defined as 50 µm thinning in response to steroid treatment in the study eye within 1 year Recurrence of cystoid macular edema in the study eye

• Patients who have received intravitreal triamcinolone acetonide in the study eye must satisfy the following:

• The most recent dose was at least 8 weeks prior to screening No treatment-related adverse event was seen that, in the opinion of the investigator, has the potential to worsen or reoccur with study treatment.

• Female patients of childbearing potential must have a negative urine pregnancy test at the enrollment (day 0) visit (repeat at day 0 if greater than 14 days past Screening Visit) Aphakia or pseudophakia in the study eye

Locations
United States
Massachusetts
MEEI
RECRUITING
Boston
Contact Information
Primary
Demetrios Vavvas, M.D., Ph.D.
demetrios_vavvas@meei.harvard.edu
617-573-4174
Backup
Odeta Dyrmishi
Odeta_dyrmishi@meei.harvard.edu
617-573-6823
Time Frame
Start Date: 2021-03-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 6
Treatments
Experimental: Dexamethasone
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) of Dexamethasone, up to 300 μg per day with a total release of 1,100 μg over 7 days
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov

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