Dexamethasone-releasing contact lens for recurrent cystoid macular edema
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
This pilot will test a dexamethasone-releasing contact lens to see if it's safe, tolerable, and comfortable for adults with recurrent cystoid macular edema.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Drugs / interventions | bevacizumab, ranibizumab |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04225611 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label Phase A pilot will test a dexamethasone-eluting therapeutic contact lens (TCL-DDS) in up to six adults with recurrent cystoid macular edema. Participants will wear the TCL-DDS in one eye for one week with close monitoring at 1 hour, 6 hours, 24 hours, 3 days, and 7 days, and then have weekly safety visits for three additional weeks after lens removal. A one-hour run-in with a commercial contact lens will identify subjects who can tolerate lens wear prior to TCL-DDS placement, and safety endpoints focus on ocular adverse events identified by eye exam through day 28. If safety is acceptable after review, a subsequent Phase B will study effectiveness, but this submission covers only the Phase A safety/feasibility portion.
Who should consider this trial
Good fit: Adults 18–85 with center-involving recurrent cystoid macular edema who still respond to anti-inflammatory eye drops, have central retinal thickness >300 µm, corneal thickness 480–620 µm, and visual acuity between 20/400 and 20/25 are the intended candidates for Phase A.
Not a fit: Patients who already require intravitreal steroid injections, have corneal thickness outside the 480–620 µm range, active ocular infection, significant ocular surface disease, or other conditions preventing contact lens wear are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive, sustained steroid delivery option that reduces the need for frequent eye drops or intravitreal injections.
How similar studies have performed: Drug-eluting contact lenses are an emerging technology with promising preclinical and limited early human data, but clinical effectiveness for treating macular edema is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 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 Exclusion Criteria 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. Study Eye \[This exclusion has been removed.\] Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., fibrosis, retinal atrophy, severe macular ischemia, extensive macular laser scarring or atrophy) Any ocular condition in the study eye that in the opinion of the investigator would prevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, or symblepharon) Use of non-steroidal anti-inflammatory eye drops (NSAID) or steroid drops within 1 month prior to screening Presence of any other condition in the study eye severe enough to prevent improvement in visual acuity despite reduction in macular edema History of advanced glaucoma / optic nerve head change consistent with glaucoma damage, and/or advanced glaucomatous visual field loss in the study 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.
Where this trial is running
Boston, Massachusetts
- Meei — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Demetrios Vavvas, M.D., Ph.D.
- Email: demetrios_vavvas@meei.harvard.edu
- Phone: 617-573-4174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.