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

Sponsor
Ain Shams University
Study ID
NCT05861466
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

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.
  • 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1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.

Study Details

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 . \]

Key Dates

First listed
May 16, 2023
Start date
Jan 1, 2023
Status verified
Nov 2024
Primary completion
Nov 24, 2024
Completion
Nov 24, 2024

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Group A
    Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.
  • Active Comparator: Group B
    Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.

Primary Outcome Measure

the acute change in angiographic parameters [ Time Frame: 1 day ]

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