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NCT04576689
Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - a Sustained, Low Dose Dexamethasone Therapy
Phase 2 trial testing IBE-814 70ug in Diabetic Macular Oedema in 60 participants. Completed in 15 March 2024.
25 April 2023
Quick facts
| Lead sponsor | Ripple Therapeutics Pty Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 30 October 2020 |
| Primary completion | 25 April 2023 |
| Estimated completion | 15 March 2024 |
| Sites | 21 locations across Hong Kong, Canada, New Zealand, Australia |
Drugs / interventions tested
- IBE-814 70ug — full drug profile →
- IBE-814 140ug — full drug profile →
Conditions studied
- Diabetic Macular Oedema — all drugs for Diabetic Macular Oedema →
- Retinal Vein Occlusion with Macular Oedema — all drugs for Retinal Vein Occlusion with Macular Oedema →
Sponsor
Ripple Therapeutics Pty Ltd — full company profile →
Who can join
45 and older, any sex, with Diabetic Macular Oedema or Retinal Vein Occlusion with Macular Oedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is a phase II, multi-center, single-masked (assessors) dose-ranging study designed to evaluate the comparative safety and preliminary efficacy of two dosage regimens of the IBE-814 IVT Dexamethasone Implant in patients with DMO and RVO.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Risk Factors and Treatment Strategy for Retinal Vascular Occlusive Diseases.
Terao R, Fujino R, Ahmed T. · · 2022 · cited 29× · PMID 36362567 · DOI 10.3390/jcm11216340 -
Retinal Vein Occlusion-Background Knowledge and Foreground Knowledge Prospects-A Review.
Lendzioszek M, Bryl A, Poppe E, Zorena K, et al · · 2024 · cited 11× · PMID 38999513 · DOI 10.3390/jcm13133950 -
Biomaterial Drug Delivery Systems for Prominent Ocular Diseases.
Sapowadia A, Ghanbariamin D, Zhou L, Zhou Q, et al · · 2023 · cited 11× · PMID 37514145 · DOI 10.3390/pharmaceutics15071959 -
Hype vs. Health: How Approved Nanomedicines Have Met (or Missed) Early Predictions.
Fröhlich E. · · 2026 · PMID 41823739 · DOI 10.3390/nano16050284
Verify or expand the search:
- PubMed search for NCT04576689
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Macular Oedema
Currently open trials in the same condition.
- NCT06908876 — A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME） · Phase 2 · 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 NCT04576689 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ripple Therapeutics Pty Ltd
- Last refreshed: 21 March 2025
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/NCT04576689.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing