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NCT03396861 · ClinicalTrials.gov registry record · Phase 1
Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept
A Phase 1 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03396861 is a Phase 1 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT03396861, a Phase 1 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not responded well to first-line standard of care treatment (eye drops). Pseudophakic cystoid macular edema (CME) is swelling of the retina that can occur weeks or years after cataract surgery and typically results in decreased vision. Subconjunctival injections are injections placed just beneath the clear membrane (conjunctiva) of the eye. A recent report of one patient who received two subconjunctival injections of a similar medication to the one being studied here indicated that subconjunctival injections of this class of medication may be an effective and less invasive alternative to intravitreal injections for pseudophakic CME. Because of the similarity of the drugs and the patient's treatment success, we would like to see if subconjunctival injection(s) of aflibercept will work in treating pseudophakic CME. If successful, the risk of an intraocular infection and glaucoma that comes with standard of care treatments might be greatly reduced.
Interventions
- DRUG Aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2020-01-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03396861
The ClinicalTrials.gov registry entry for NCT03396861 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aflibercept is the first listed.
NCT03396861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03396861 about?
NCT03396861 is a clinical study titled "Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept". This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not responded well to first-line standard of care treatment (eye drops). Pseudophakic cystoid macular edema (C...
What is the current status of trial NCT03396861?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2019-02-22. Estimated completion is 2020-01-02.
What interventions are being tested in trial NCT03396861?
The interventions under investigation include: Aflibercept (DRUG).
Who is sponsoring clinical trial NCT03396861?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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