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NCT04225611 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cystoid Macular Edema, sponsored by Massachusetts Eye and Ear Infirmary.

Recruiting
Registry status
Phase 1
Development phase
6
Enrollment target
1
Study location

NCT04225611 is a Phase 1 study of Cystoid Macular Edema that is actively recruiting participants, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 6 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04225611, a Phase 1 study of Cystoid Macular Edema, is actively recruiting participants, sponsored by Massachusetts Eye and Ear Infirmary.

RECRUITING
Registry status
Phase 1
Development phase
6 participants
Enrollment target
1
Study location

Study 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. 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.

Conditions Studied

Interventions

  • DRUG Dexamethasone

Study Locations (1)

Massachusetts

  • MEEI - Boston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-03-15
Est. Completion 2027-12-31
Phase Phase 1

What the Registry Record Tells You About NCT04225611

The ClinicalTrials.gov registry entry for NCT04225611 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystoid Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Dexamethasone is the first listed.

NCT04225611 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04225611 about?

NCT04225611 is a clinical study titled "Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema". 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 ...

What is the current status of trial NCT04225611?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-03-15. Estimated completion is 2027-12-31.

What conditions does trial NCT04225611 study?

This clinical trial studies the following conditions: Cystoid Macular Edema.

What interventions are being tested in trial NCT04225611?

The interventions under investigation include: Dexamethasone (DRUG).

Who is sponsoring clinical trial NCT04225611?

This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04225611 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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