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

Study Overview
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Brief Summary
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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 . ]

Official Title
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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]

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: intra-vitreal injection of Ranibizumab
* Procedure: anterior chamber paracentesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis. | Drug: intra-vitreal injection of Ranibizumab<br>* 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.<br>|
| Active Comparator: Group B<br>Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis. | Drug: intra-vitreal injection of Ranibizumab<br>* 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.<br>Procedure: anterior chamber paracentesis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the acute change in angiographic parameters | OCTA of macula and peripapillary region with documentation of vessel density | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the acute change in intra-ocular pressure | Goldman applanation tonometry for evaluation of IOP | 1 day |