Effect of PPV+ILM Peeling +/- Subretinal Injection of Rin... | NCT06271473

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2023Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Feb 14, 2024

First Submission Date that Met QC Criteria

Feb 14, 2024

First Posted Date

Feb 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2024

Last Update Posted Date

Aug 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Azza MA Said, MD	Contact	2001006228992		dr_azza_22@hotmail.com
David G Samuel, Mscc	Contact	2001064442469		david.samuel.ophth@gmail.com

Overall Officials

Name	Affiliation	Role
Abdelrahman G Salman, MD	professor at Ain Shams university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams university	Active, not recruiting	Cairo			Egypt
Ain Shams university

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative