Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME

Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema

To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.

Study Overview

• Status: Recruiting
• Conditions: Efficacy; Safety
• Intervention / Treatment: Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

Detailed Description

In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME.

To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azza MA Said, MD; Phone Number: 2001006228992; Email: dr_azza_22@hotmail.com
• Study Contact Backup: Name: David G Samuel, Mscc; Phone Number: 2001064442469; Email: david.samuel.ophth@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain shams university
    • Contact: Azza MA Said, MD; Phone Number: +201006228992; Email: dr_azza_22@hotmail.com
    • Contact: David G Samuel, Msc; Phone Number: +201064442469; Email: david.samuel.ophth@gmail.com
  • Cairo, Egypt
    • Active, not recruiting
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: above 40 years old.

  • Patients with type two diabetes mellitus of more than 5 years duration.
  • Patients with Best corrected visual acuity better than 3/60.
  • Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit.
  • No evidence of vitreomacular traction.
  • Lens status: Pseudophakia or clear crystalline lens.

Exclusion Criteria:

Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).

• Ischemic maculopathy by FFA.
• Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally.
• Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula.
• Presence of proliferative diabetic fibrovascular membranes threatening or at the macula.
• Presence of diabetic optic atrophy or neuropathy.
• Presence of neovascular glaucoma.
• Cataractous lens either preoperatively or as intra or postoperative complication.
• Vitrectomized Eyes.
• A prior intraocular surgery within the past six-months.
• Lost follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subjecting to vitrectomy + ILM peeling only	Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.; vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
Active Comparator: subjecting to vitrectomy + ILM peeling + planned foveal detachment	Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.; vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in CMT by OCT at final visit	decrease or increase in central macular thickness by OCT	after 1 month and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in BCVA at final visit	decrease or increase in best corrected visual acuity	after 1 month and 3 months

Other Outcome Measures

Outcome Measure	Time Frame
any surgical complication or recurrence of DME	after 1 month and 3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Abdelrahman G Salman, MD, professor at Ain Shams university

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: internal limiting membrane peeling; pars plana vitrectomy; refractory diabetic macular edema; subretinal injection of ringer lactate
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: AinShamsU3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No