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Completed

NCT Number: NCT05861466

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

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 . ]

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Key information

Conditions

Diabetic Macular Edema

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain shams university

Cairo, Cairo Governorate, 11591, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. the acute change in angiographic parameters

    Time frame: 1 day

    OCTA of macula and peripapillary region with documentation of vessel density

Secondary outcomes

  1. the acute change in intra-ocular pressure

    Time frame: 1 day

    Goldman applanation tonometry for evaluation of IOP

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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