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

NCT05861466 | Completed Phase 4 FDA Drug

• 1 other identifier: MD 1692022
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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 . \]

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• the acute change in angiographic parameters

  OCTA of macula and peripapillary region with documentation of vessel density

  1 day

Secondary Outcomes (1)

• the acute change in intra-ocular pressure

  1 day

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: intra-vitreal injection of Ranibizumab

Group B

ACTIVE COMPARATOR

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

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

Interventions

intra-vitreal injection of Ranibizumab DRUG

The intravitreal injection will be performed with ranibizumab (0.5 mg/0.05 mL through a 27-gauge needle that will be inserted into the sclera 3.5 mm from the corneal limbus in pseudophakic patients, and 4 mm in phakic patients.

Group A; Group B

anterior chamber paracentesis PROCEDURE

A 27-gauge needle on a 1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.

Group B

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, 11591, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of ophthalmology

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 16, 2023
• Study Start: January 1, 2023
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)