Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A
NCT ID: NCT05861466
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2023-01-01
2024-11-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group A
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.
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.
Group B
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
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.
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1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
60 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Amr Sanad
Assistant lecturer of ophthalmology
Locations
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Ain shams university
Cairo, Cairo Governorate, Egypt
Countries
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Other Identifiers
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MD 1692022
Identifier Type: -
Identifier Source: org_study_id
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