Actively Recruiting
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-11-26
6
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and have not yet received intravitreal steroid injections
- Corneal thickness between 480 and 620 �b5m in the study eye by anterior segment OCT
- Diagnosis of cystoid macular edema in the study eye involving the center of the macula with retinal cysts, thickening, or subretinal fluid
- Visual acuity between 20/400 and 20/25 in the study eye, measured by pinhole VA
- Retinal thickness above 300 �b5m in the central macular subfield of the study eye at screening
- History of positive response to steroid treatment defined as 50 �b5m thinning in response to steroid in the study eye within 1 year
- Recurrence of cystoid macular edema in the study eye
- If previously treated with intravitreal triamcinolone acetonide, most recent dose was at least 8 weeks prior to screening with no related adverse events
- Female patients of childbearing potential must have a negative urine pregnancy test at enrollment
- Aphakia or pseudophakia in the study eye
You will not qualify if you...
- Systemic renal failure requiring dialysis within 6 months prior to screening
- Use of systemic steroids or immunosuppressants within 1 month to 6 months prior to screening or anticipated use during the study
- Use of oral carbonic anhydrase inhibitors within 1 month of screening
- Known allergy or hypersensitivity to study medication or components
- Positive medical history for HIV
- Any condition impairing ability to comply with study requirements
- Pregnancy, nursing, or planning pregnancy without reliable contraception
- Participation in another investigational study within 30 days prior to screening
- Conditions posing significant risk or interfering with study participation as judged by investigator
- Contraindication to pupil dilation in either eye
- Active ocular infection in either eye at screening
- History of central serous chorioretinopathy in either eye
- History of elevated intraocular pressure from steroid treatment requiring multiple anti-glaucoma medications
- Failure to respond to prior steroid injections in either eye
- Ocular conditions preventing 15-letter vision improvement or contact lens wear in study eye
- Use of NSAID or steroid eye drops within 1 month prior to screening
- Severe ocular conditions preventing vision improvement despite macular edema reduction
- History of advanced glaucoma or optic nerve damage in study eye
- Ocular hypertension greater than 25 mm Hg at screening
- Active optic disc, retinal neovascularization, or rubeosis iridis in study eye
- History of herpetic infection in study eye or adnexa
- Media opacity preventing evaluation in study eye
- Recent intraocular surgery or laser in study eye within 30 days
- History of pars plana vitrectomy within 3 months prior to screening
- Recent use of certain intravitreal agents within 3 to 6 months prior to screening
- Inability to wear a commercial contact lens with TCL-DDS dimensions for 1 hour
- Presence of guttae, Descemet's folds, or corneal neovascularization with vessels extending 2 mm into cornea in study eye
- Non-study eye pinhole score less than 19 letters at screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MEEI
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
Demetrios Vavvas, M.D., Ph.D.
CONTACT
O
Odeta Dyrmishi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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