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Clinical trial

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]

ID
Name
MD 1692022
Description
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 . \]
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-04-01
Trial end
2024-04-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Group A, Group B
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1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.
Arms:
Group B
Size
100
Primary endpoint
the acute change in angiographic parameters
1 day
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-05-16

1 organization

1 product

1 indication

Organization
Ain Shams University
Product
Ranibizumab
Indication
Diabetic Macular Edema