Last reviewed · How we verify
NCT03660345
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
Phase 3 trial testing PPV/MP in Diabetic Retinopathy in 11 participants. Completed in 4 May 2021.
4 May 2021
Quick facts
| Lead sponsor | Rush Eye Associates |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 4 September 2018 |
| Primary completion | 4 May 2021 |
| Estimated completion | 4 May 2021 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- PPV/MP
- Intravitreal injection — full drug profile →
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
- Macular Edema — all drugs for Macular Edema →
Sponsor
Rush Eye Associates
Who can join
Adults 20 to 90, any sex, with Diabetic Retinopathy or Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pars Plana Vitrectomy with Internal Limiting Membrane Peeling for Treatment-Naïve Diabetic Macular Edema: A Prospective, Uncontrolled Pilot Study.
Rush RB, Rush SW. · · 2021 · cited 7× · PMID 34188440 · DOI 10.2147/opth.s320214
Verify or expand the search:
- PubMed search for NCT03660345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PPV/MP
Trials testing the same drug.
- NCT03660371 — ILM Peeling in PDR Patients Undergoing PPV for VH · NA · completed
Other recruiting trials for Diabetic Retinopathy
Currently open trials in the same condition.
- NCT07255326 — Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes · NA · recruiting
- NCT06782997 — Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diab · recruiting
- NCT07002372 — Effect of Video Viewing on Intravitreal Injection Experience · NA · recruiting
- NCT06713720 — Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy · NA · recruiting
- NCT06892353 — AI-Powered DIY Screening System for Diabetic Retinopathy · NA · recruiting
Other Rush Eye Associates trials
Trials by the same sponsor.
- NCT04903301 — Patient Satisfaction With Contoura Vision Topography-Guided LASIK · NA · completed
- NCT04380077 — Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics · NA · unknown
- NCT04380064 — Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy · NA · unknown
- NCT03660371 — ILM Peeling in PDR Patients Undergoing PPV for VH · NA · completed
- NCT03660384 — Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy · NA · completed
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 NCT03660345 (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 Rush Eye Associates
- Last refreshed: 2 December 2021
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/NCT03660345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing