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Comparative Study Between IVI of Ranibizumab With and Without Prior ACP in Patients With DME Using OCT-A - Trial NCT05861466

Access comprehensive clinical trial information for NCT05861466 through Pure Global AI's free database. This Phase 4 trial is sponsored by Ain Shams University and is currently Recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 100 participants.

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NCT05861466
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05861466
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Comparative Study Between IVI of Ranibizumab With and Without Prior ACP in Patients With DME Using OCT-A
Comparative Study Between Intravitreal Injection of Ranibizumab With and Without Prior Anterior Chamber Paracentesis in Patients With Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]

Study Focus

Diabetic Macular Edema

intra-vitreal injection of Ranibizumab

Interventional

drug

Sponsor & Location

Ain Shams University

Cairo, Egypt

Timeline & Enrollment

Phase 4

Jan 01, 2023

Apr 01, 2024

100 participants

Primary Outcome

the acute change in angiographic parameters

Summary

The goal of this clinical trial is to to evaluate the changes in retinal microvasculature
 secondary to intra-ocular pressure changes post intra-vitreal injection in patients with
 diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on
 such changes if present .
 
 The main question[s]it aims to answer are:
 
 โ€ข[is there any effect of post intra-vitreal injection IOP spikes on retinal
 microvasculature?] โ€ข[is there any effect of Prior Anterior Chamber Paracentesis?]
 Participants in group A will be subjected to an identified approved treatment( intra-vitreal
 injection)& Participants in group B will be subjected to a prior ACP with the intra-vitreal
 injection . ]

ICD-10 Classifications

Diabetic retinopathy
Other specified diabetes mellitus with ophthalmic complications
Unspecified diabetes mellitus with ophthalmic complications
Diabetic cataract
Type 2 diabetes mellitus with ophthalmic complications

Data Source

ClinicalTrials.gov

NCT05861466

Non-Device Trial