CompletedPhase 4

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

Egypt102 participantsStarted 2023-01-01

Plain-language 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: •\[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?\] •\[is there any effect of Prior Anterior Chamber Paracentesis?\] 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 . \]

Who can participate

Age range40 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with diabetes mellitus type II. * Patients with visual acuity \> 0.1, able to fixate and with clear visual media. * Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP. Exclusion Criteria: * Age under 40 years. * Poorly controlled diabetics (HbA1C greater than 9.0%) * Proliferative diabetic retinopathy. * OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion) * Neovascular AMD in the study eye. * History of glaucoma. * Tilted disc and optic disc anomalies. * One-eyed patients. * Usage of systemic or topical corticosteroids. * Patients with a history of intraocular surgery other than cataract surgery. * Systemc diseases rather than hypertension and diabetes mellitus. * Corneal opacities that might hinder acquisition of good quality OCT images.

What they're measuring

the acute change in angiographic parameters

Timeframe: 1 day

Trial details

NCT IDNCT05861466

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-24