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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: Recruiting Phase 1 study of Cystoid Macular Edema, sponsored by Massachusetts Eye and Ear Infirmary.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of ocular infection incidents for the duration of the study
Conditions Studied
Interventions
- DRUG Dexamethasone
Study Locations (1)
Massachusetts
- MEEI - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04225611 shows while recruiting
NCT04225611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cystoid Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04225611's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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