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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05861466

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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 . ]

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: intra-vitreal injection of Ranibizumab Procedure: anterior chamber paracentesis	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

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]

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A 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 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.
Active Comparator: Group B 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 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.

Arm

Intervention/Treatment

Active Comparator: Group A

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

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.

Active Comparator: Group B

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

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.

Outcome Measures

Primary Outcome Measures

the acute change in angiographic parameters [1 day]
OCTA of macula and peripapillary region with documentation of vessel density

Secondary Outcome Measures

the acute change in intra-ocular pressure [1 day]
Goldman applanation tonometry for evaluation of IOP

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams university	Cairo		Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amr Sanad, Assistant lecturer of ophthalmology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05861466

Other Study ID Numbers:

MD 1692022

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Macular Edema

Ranibizumab

Study Results

No Results Posted as of May 16, 2023