Therapeutic Contact Lens for Macular Edema

(ContactLens Trial)

Overseen By Demetrios Vavvas, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Systemic steroids, Oral carbonic anhydrase

Disqualifiers: Renal failure, HIV, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 1 week

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I have been diagnosed with a specific type of swelling in the center of my retina.

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

Exclusion Criteria

My study eye is clear and can be evaluated.

I had a specific eye surgery (pars plana vitrectomy) in the last 3 months.

I haven't used any immune system affecting drugs in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Run-in Period

Participants wear a commercial contact lens for 1 hour to assess comfort and fit

1 hour

1 visit (in-person)

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

1 week

5 visits (in-person), 2 visits (phone)

Follow-up

Participants are monitored for safety with weekly examinations for 3 weeks after TCL-DDS removal

3 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The trial is testing a dexamethasone-eluting contact lens for safety, tolerability, comfort, and feasibility in treating recurrent cystoid macular edema. Participants will wear this therapeutic lens to see if it effectively delivers medication directly to the eye.

How Is the Trial Designed?

Group I: Dexamethasone Experimental Treatment 1 Intervention

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

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+