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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: intra-vitreal injection of Ranibizumab; Procedure: anterior chamber paracentesis

Study type: Interventional

Funder types: Other

Identifiers

NCT05861466

MD 1692022

Details and patient eligibility

About

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 . ]

Enrollment: 102 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

Group A

Active Comparator group

Description:

Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.

Treatment:

Drug: intra-vitreal injection of Ranibizumab

Group B

Active Comparator group

Description:

Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.

Treatment:

Procedure: anterior chamber paracentesis

Drug: intra-vitreal injection of Ranibizumab