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

Diabetic Macular Edema Clinical Trial

Official 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]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861466
• Other study ID #: MD 1692022
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 . ]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• intra-vitreal injection of Ranibizumab
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.

Procedure:
• anterior chamber paracentesis
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.

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the acute change in angiographic parameters	OCTA of macula and peripapillary region with documentation of vessel density	1 day
Secondary	the acute change in intra-ocular pressure	Goldman applanation tonometry for evaluation of IOP	1 day