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

NCT06271473 | Recruiting DMC

• 1 other identifier: AinShamsU3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Efficacy; Safety

Keywords

refractory diabetic macular edema; internal limiting membrane peeling; pars plana vitrectomy; subretinal injection of ringer lactate

Outcome Measures

Primary Outcomes (1)

• change in CMT by OCT at final visit

  decrease or increase in central macular thickness by OCT

  after 1 month and 3 months

Secondary Outcomes (1)

• change in BCVA at final visit

  after 1 month and 3 months

Other Outcomes (1)

• any surgical complication or recurrence of DME

  after 1 month and 3 months

Study Arms (2)

subjecting to vitrectomy + ILM peeling only

ACTIVE COMPARATOR

Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

subjecting to vitrectomy + ILM peeling + planned foveal detachment

ACTIVE COMPARATOR

Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

Interventions

vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. PROCEDURE

vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

subjecting to vitrectomy + ILM peeling + planned foveal detachment; subjecting to vitrectomy + ILM peeling only

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams university

Cairo, Egypt

ACTIVE NOT RECRUITING

Ain Shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Abdelrahman G Salman, MD

  professor at Ain Shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azza MA Said, MD

CONTACT

2001006228992; dr_azza_22@hotmail.com

David G Samuel, Mscc

CONTACT

2001064442469; david.samuel.ophth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 eyes of 20 patients will be divided randomly into 2 groups: * Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only * Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: August 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-02

Locations

EG (2)