Image

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

Recruiting
40 - 60 years of age
Both
Phase 4

Powered by AI

Overview

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 . ]

Eligibility

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 details

Diabetic Macular Edema

NCT05861466

Ain Shams University

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.