Therapeutic Contact Lens for Macular Edema
(ContactLens Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new contact lens that slowly releases dexamethasone, a corticosteroid, to treat recurrent cystoid macular edema, a condition that causes swelling in the eye and affects vision. Researchers seek to determine if this contact lens is safe, comfortable, and effective in delivering the medication to the eye. Suitable participants have experienced swelling in the macula that improves with steroid treatments but recurs. As a Phase 1, Phase 2 trial, this study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using certain medications before participating. You must not use systemic steroids, oral carbonic anhydrase inhibitors, or non-steroidal anti-inflammatory eye drops within a month before the trial. Additionally, you should not use immunosuppressants or certain other medications within six months prior to the trial.
What prior data suggests that this therapeutic contact lens is safe for treating macular edema?
Research has shown that dexamethasone, used in various forms for eye conditions, is generally safe. In studies where patients received a dexamethasone implant for macular edema, the treatment was well-tolerated over a year. Serious side effects were rare, though some patients experienced mild eye-related issues.
The safety of the contact lens delivering dexamethasone is still under investigation. Current research examines how well people tolerate this method and any potential eye problems. Overall, existing evidence suggests that dexamethasone treatments are usually safe for eye conditions, but this specific method is still being reviewed for its safety and comfort.12345Why do researchers think this study treatment might be promising?
Unlike current treatments for macular edema, which often involve repeated eye injections, this new therapeutic contact lens delivers dexamethasone directly to the eye. This innovative drug delivery system releases up to 300 μg of dexamethasone per day, totaling 1,100 μg over a week. Researchers are excited because this method could provide a more consistent and less invasive treatment option, potentially improving patient comfort and adherence.
What evidence suggests that this therapeutic contact lens is effective for macular edema?
Research has shown that dexamethasone, a type of steroid, can help with eye conditions like macular edema. Studies have found that slow-release dexamethasone implants can significantly improve vision and reduce eye swelling. Specifically, patients who received repeated dexamethasone injections experienced better vision clarity. One study found that dexamethasone might outperform other treatments, such as aflibercept, in improving vision. In this trial, participants will use a therapeutic contact lens designed to deliver dexamethasone directly to the eye, potentially reducing swelling and enhancing sight for those with macular edema.15678
Are You a Good Fit for This Trial?
Adults aged 18-85 with recurrent cystoid macular edema who've previously responded to steroid treatments can join. They must have specific levels of visual acuity and retinal thickness, and not be at the intravitreal injection phase or beyond. Pregnant women or those on certain medications like systemic steroids are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Period
Participants wear a commercial contact lens for 1 hour to assess comfort and fit
Treatment
Participants wear the TCL-DDS in one eye for 7 days with examinations at 1 hour, 6 hours, 24 hours, 3 days, and 7 days
Follow-up
Participants are monitored for safety with weekly examinations for 3 weeks after TCL-DDS removal
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor