Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema

NCT04225611 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2019P001550
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS.
3. 3.Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.

Conditions

Cystoid Macular Edema

Keywords

contact lens; drug; cystoid; macular edema

Outcome Measures

Primary Outcomes (3)

• Occurrence of Contact Lens Related Ocular Infection

  Number of ocular infection incidents for the duration of the study

  28 Days

• Occurrence of Corneal epithelial Defect

  Number of corneal epithelial defects incidents for the duration of the study

  28 Days

• Occurrence of ocular hypertension greater than 28

  Number of ocular hypertension incidents for the duration of the study (ocular hypertension greater than 28)

  28 Days

Secondary Outcomes (5)

• OCT Macular Thickness Change

  28 Days

• Percentage of subject that achieve OCT Macular Thickness Decrease of 50 μm

  28 Days

• Changes is Visual Acuity

  28 Days

• Percentages of subjects with 15 letter gain

  28 Days

• Percentage of subjects that require rescue Medication

  Day 21

Other Outcomes (1)

• Changes in Modified Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

  28 Days

Study Arms (1)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

The investigators have developed a topically-applied corticosteroid-delivery system that has the potential to treat recurrent cystoid macular edema with fewer risks to patient, and more dose control. The system is comprised of a drug-polymer film that is completely encapsulated within the periphery of a hydrogel that is commonly used to make contact lenses.

Also known as: (TCL-DDS)

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Systemic Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to screening Use of systemic steroids (e.g., oral, intravenous, intra-articular, epidural, intrabursal, inhaled, or intranasal) within 1 month prior to the qualification/baseline visit or anticipated use at any time during the study Use of oral carbonic anhydrase inhibitor within 1 month of screening Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within 6 months prior to screening or anticipated use at any time during the study Known allergy or hypersensitivity to the study medication or its components Medical history positive for HIV Any condition (including inability to read visual acuity charts or language barrier) which precludes patient's ability to comply with study requirements including completion of the study Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception Participation in an investigational drug or device study within the 30 days prior to screening Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
• Both Eyes Contraindication to pupil dilation in either eye Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening History of central serous chorioretinopathy in either eye
• History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following:
• ≥ 10 mm Hg increase in IOP from screening visit with an absolute IOP ≥ 25 mm Hg required therapy with 3 or more anti-glaucoma medications History of failure to respond positively to a periocular or intravitreal steroid injection in either eye.
• Ocular hypertension in the study eye at screening visit determined by the following:
• IOP \> 25 mm Hg if taking no anti-glaucoma medications Active optic disc or retinal neovascularization in the study eye at screening Active or history of choroidal neovascularization in the study eye Presence of rubeosis iridis in the study eye at screening History of herpetic infection in the study eye or adnexa Media opacity in the study eye at screening that precludes clinical and photographic evaluation (including but not limited to preretinal or vitreous hemorrhage, lens opacity) Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 30 days prior to screening History of pars plana vitrectomy in the study eye within 3 months prior to screening History of use of intravitreal bevacizumab, ranibizumab or pegaptanib in the study eye within 3 months prior to screening Treated with intravitreal injections of dexamethasone implant 0.7 mg (Ozurdex®) within 6 months of screening History of use of any intravitreal agent in the study eye other than corticosteroid, bevacizumab, ranibizumab, or pegaptanib, or intravitreal doses of triamcinolone acetonide \> 4mg, bevacizumab \> 1.25 mg, ranibizumab \> 0.5 mg, or pegaptanib \> 0.3 mg within 3 months prior to screening.
• Except at the time of surgery, any periocular depot of steroids to the study eye within 3 months prior to screening Inability to comfortably wear a commercial contact lens (Kontur) that has the same dimensions as the TCL-DDS during a 1 hour run-in period Presence of guttae or descemet's folds in the study eye. Corneal neovascularization with presence of blood vessels 2 mm into the cornea.
• Non-study Eye Pinhole score \<19 letters in the non-study eye at screening visit.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

MEEI

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Macular Edema

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Demetrios Vavvas, M.D., Ph.D.

CONTACT

617-573-4174; demetrios_vavvas@meei.harvard.edu

Odeta Dyrmishi

CONTACT

617-573-6823; Odeta_dyrmishi@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking in Phase A of this trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Principal Investigator

Model Details: The study begins with phase A, which is an open label study in that will enroll up to 6 subjects. The goal of this phase is to have 3 subjects complete the study. The enrollment number is 6 in order to accommodate for withdraws and/or terminations (for reasons other than adverse event to the study intervention and include loss of the lens before 7 days). Subjects will wear the TCL-DDS in one eye for 3 days during which time they will be closely followed with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days. After the TCL-DDS is removed after 3 days of wear, the subjects will be followed with weekly examinations for 3 additional weeks for evaluation of safety.

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: January 13, 2020
• Study Start: March 15, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)