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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: intra-vitreal injection of Ranibizumab; Procedure: anterior chamber paracentesis

• Registration Number: NCT05861466
• Lead Sponsor: Ain Shams University

Brief 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 . \]

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-16
• Status Verified: 2024-11
• Primary Completion: 2024-11-24
• Study Completion: 2024-11-24
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	intra-vitreal injection of Ranibizumab	Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.
Group B	intra-vitreal injection of Ranibizumab	Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
Group B	anterior chamber paracentesis	Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.

Primary Outcome Measures

Name	Time	Method
the acute change in angiographic parameters	1 day	OCTA of macula and peripapillary region with documentation of vessel density

Secondary Outcome Measures

Name	Time	Method
the acute change in intra-ocular pressure	1 day	Goldman applanation tonometry for evaluation of IOP

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt