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NCT05476042

The Effect of Erythropoietin in the Treatment of Scleral Necrosis

Status unknown Phase 2, PHASE3 Last updated 27 July 2022
What this trial tests

Phase 2, PHASE3 trial testing Prescription of placebo in Conjunctival and Scleral Avascular Lesions in 60 participants. Status unknown.

Timeline
14 August 2022
Primary endpoint
1 November 2022
1 December 2022

Quick facts

Lead sponsorShahid Beheshti University of Medical Sciences
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date14 August 2022
Primary completion1 November 2022
Estimated completion1 December 2022
Sites1 location across Iran

Drugs / interventions tested

Conditions studied

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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Other Shahid Beheshti University of Medical Sciences trials

Trials by the same sponsor.

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