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New treatment option for Cystoid Macular Edema
Official title Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
ClinicalTrials.gov ID: NCT04225611
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for cystoid macular edema.
Also referred to as (TCL-DDS).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- For Phase B, patients who only respond to steroid intravitreal injections (anti-inflammatory drops are no longer therapeutically working for these...
- 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...
- Visual acuity between 20/400 and 20/25 in the study eye, measured by pinhole VA.
You likely can't join if
- Systemic Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to screening Use of systemic steroids (e.g., oral...
- Both Eyes Contraindication to pupil dilation in either eye Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) 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...
- 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...
- Ocular hypertension in the study eye at screening visit determined by the following:
See the full eligibility 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...
- 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...
- 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...
- 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
- 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)...
- 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...
- 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...
- 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...
- 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...
- Non-study Eye Pinhole score \<19 letters in the non-study eye at screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.