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NCT05582577
Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema
Phase 2, PHASE3 trial testing Intravitreal bevacizumab injection with subthreshold micropulse laser in Diabetic Macular Edema in 30 participants. Status unknown.
15 October 2023
Quick facts
| Lead sponsor | Shahid Beheshti University of Medical Sciences |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 15 October 2022 |
| Primary completion | 15 October 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Intravitreal bevacizumab injection with subthreshold micropulse laser
- Intravitreal bevacizumab injection alone — full drug profile →
Conditions studied
- Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
Sponsor
Shahid Beheshti University of Medical Sciences
Who can join
Adults 18 to 40, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05582577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05582577 (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 Shahid Beheshti University of Medical Sciences
- Last refreshed: 17 October 2022
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/NCT05582577.
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