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NCT06038968
Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy
EARLY_PHASE1 trial testing Methotrexate 25 MG/ML in Diabetic Retinopathy in 60 participants. Completed in 1 January 2024.
1 November 2023
Quick facts
| Lead sponsor | Minia University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 1 September 2022 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Methotrexate 25 MG/ML — full drug profile →
- parsplana vitrectomy
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
- Vitreomacular Traction — all drugs for Vitreomacular Traction →
Sponsor
Minia University
Who can join
18 and older, any sex, with Diabetic Retinopathy or Vitreomacular Traction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy. The main questions it aims to answer are: 1. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy? 2. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy? Researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06038968
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Minia University trials
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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 NCT06038968 (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 Minia University
- Last refreshed: 5 February 2024
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/NCT06038968.
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