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NCT03629210: COLLIDE
Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema (COLLIDE)
Phase 2 trial testing OZURDEX in Diabetic Macular Edema. Withdrawn.
1 February 2021
Quick facts
| Lead sponsor | Pradeepa Yoganathan |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 September 2019 |
| Primary completion | 1 February 2021 |
| Estimated completion | 1 May 2021 |
Drugs / interventions tested
Conditions studied
- Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
Sponsor
Pradeepa Yoganathan
Who can join
18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Central Subfield Thickness
Time frame: At 24 Weeks
Foveal central subfield (FCS) thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid.
Sponsor's own description
COLLIDE is a multi-center, open-label, 1:1 randomized study looking at the effects of aflibercept (AFL; 2.0mg) plus OZURDEX (DEX; 0.7mg) implant combination therapy versus DEX monotherapy in phakic or pseudophakic eyes with center-involved DME that have demonstrated prior incomplete response to 3-6 anti-VEGF treatment in 3-9 months. The primary outcome will be 24 week central subfield thickness. Secondary outcomes include the change in ETDRS BCVA letters, number of re-injections and re-injection interval, proportion of eyes with 15- and 10- ETDRS letter gained/lost, proportion of eyes with PDR as per Optos color and FA at the study completion (24+/- 2 weeks) and OCT and OCT angiography biomarkers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03629210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of OZURDEX
Trials testing the same drug.
- NCT03908307 — Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China · Phase 4 · completed
Other recruiting trials for Diabetic Macular Edema
Currently open trials in the same condition.
- NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
- NCT06984822 — Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant · NA · recruiting
- NCT07038967 — Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification · recruiting
- NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
- NCT06549023 — Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy · NA · recruiting
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 NCT03629210 (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 Pradeepa Yoganathan
- Last refreshed: 11 November 2019
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/NCT03629210.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing