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NCT05476042
The Effect of Erythropoietin in the Treatment of Scleral Necrosis
Phase 2, PHASE3 trial testing Prescription of placebo in Conjunctival and Scleral Avascular Lesions in 60 participants. Status unknown.
1 November 2022
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 | 60 |
| Start date | 14 August 2022 |
| Primary completion | 1 November 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Prescription of placebo — full drug profile →
- Erythropoietin prescription — full drug profile →
- Erythropoietin prescription — full drug profile →
Conditions studied
- Conjunctival and Scleral Avascular Lesions — all drugs for Conjunctival and Scleral Avascular Lesions →
Sponsor
Shahid Beheshti University of Medical Sciences
Who can join
Adults 10 to 70, any sex, with Conjunctival and Scleral Avascular Lesions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with acute avascular lesions of the conjunctiva and sclera will be included in the study. Patients will undergo a complete eye examination including a slit lamp, intraocular pressure measurement, and fundoscopy with dilated pupil. At the same time, laboratory examination including measurement of fasting blood sugar (FBS) level, complete blood count (CBC) and systemic blood pressure will be performed. Patients will be randomly divided into three groups. The groups will receive sham drops (normal saline), erythropoietin 3000 units in normal saline, and erythropoietin 6000 units in normal saline every 6 hours respectively. Meanwhile, all patients will receive the usual treatments based on the cause of scleral necrosis. Eye examinations will be done daily in the first week, every other day in the second week, and then twice a week until the complete recovery of avascular lesions. In each examination, with fluorescein staining, the size of the conjunctival epithelial defect will be determined. Also, the dimensions of the avascular area of the sclera will be determined. Other examinations include measurement of visual acuity and intraocular pressure, and the patient will be evaluated in terms of iris and retinal neovascularization. The photoslit lamp will be done before starting the study and then every week. Complete healing of the lesion is defined by complete vascularization and epithelization of the ischemia site. After the complete recovery of conjunctival and scleral necrosis, the erythropoietin drop will be stopped and the examinations including blood pressure measurement, CBC, diff and FBS will be repeated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT05476042 (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: 27 July 2022
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