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

Primary Purpose

Diabetic Macular Edema

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
intra-vitreal injection of Ranibizumab
anterior chamber paracentesis
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Macular Edema

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain shams universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.

Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.

Outcomes

Primary Outcome Measures

the acute change in angiographic parameters
OCTA of macula and peripapillary region with documentation of vessel density

Secondary Outcome Measures

the acute change in intra-ocular pressure
Goldman applanation tonometry for evaluation of IOP

Full Information

First Posted
May 2, 2023
Last Updated
May 15, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05861466
Brief Title
Comparative Study Between IVI of Ranibizumab With and Without Prior ACP in Patients With DME Using OCT-A
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]
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief 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 . ]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
Intervention Type
Drug
Intervention Name(s)
intra-vitreal injection of Ranibizumab
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
anterior chamber paracentesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
the acute change in angiographic parameters
Description
OCTA of macula and peripapillary region with documentation of vessel density
Time Frame
1 day
Secondary Outcome Measure Information:
Title
the acute change in intra-ocular pressure
Description
Goldman applanation tonometry for evaluation of IOP
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed ibrahim, lecturer
Phone
026837673
Email
M.IBRAHIM@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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