Last reviewed · How we verify
NCT04501367
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.
Phase 4 trial testing Dexamethasone Intracanalicular Insert, 0.4 mg in Vitrectomy in 60 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Kovach Eye Institute |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 27 April 2021 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dexamethasone Intracanalicular Insert, 0.4 mg — full drug profile →
- Dexamethasone Intracanalicular Insert, 0.4 mg — full drug profile →
- Prednisone acetate 1% — full drug profile →
Conditions studied
- Vitrectomy — all drugs for Vitrectomy →
- Macular Pucker — all drugs for Macular Pucker →
- Retinal Edema — all drugs for Retinal Edema →
Sponsor
Kovach Eye Institute
Who can join
18 and older, any sex, with Vitrectomy or Macular Pucker. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04501367
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Kovach Eye Institute trials
Trials by the same sponsor.
- NCT03579368 — Prospective Evaluation of the Tecnis Symfony Intraocular Lens (IOL) · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04501367 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kovach Eye Institute
- Last refreshed: 29 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04501367.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing