PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME

NCT03660345 | Completed Phase 3

• 1 other identifier: Retina 1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.

Conditions

Diabetic Retinopathy; Macular Edema

Outcome Measures

Primary Outcomes (1)

• BCVA

  Best-corrected visual acuity

  6 months

Study Arms (2)

PPV/MP

EXPERIMENTAL

Study Group: Treatment-naïve subjects with center-involved diabetic macular edema undergo pars plana vitrectomy with internal limiting membrane peeling

Procedure: PPV/MP

Intravitreal Injection

ACTIVE COMPARATOR

Control Group: Treatment-naïve subjects with center-involved diabetic macular edema undergo intravitreal ziv-aflibercept monotherapy according to a fixed treatment schedule

Drug: Intravitreal injection

Interventions

PPV/MP PROCEDURE

23 gauge Pars Plana Vitrectomy with Internal Limiting Membrane Peeling

PPV/MP

Intravitreal injection DRUG

Intravitreal ziv-Aflibercept

Intravitreal Injection

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient able and willing to provide informed consent
• Diagnosis of diabetes mellitus (type 1 or type 2) is established.
• Patient has non-proliferative diabetic retinopathy and is treatment-naïve for diabetic retinopathy in the study eye. (Patients may NOT have received treatment of any kind for diabetic retinopathy to the study eye).
• Best corrected visual acuity letter score is 20/32 or worse, and 20/400 or better at the time of randomization in the study eye.
• On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula is present in the study eye.
• Central subfield thickness on the spectral domain OCT is greater than 300 microns at the time of randomization in the study eye.
• (The investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality).
• The study eye has no history of intraocular surgery within the previous four months. Previous uncomplicated cataract surgery otherwise shall be allowed if the study eye is longer than four months out at the time of randomization.

You may not qualify if:

• Proliferative diabetic retinopathy of any kind including neovascularization of the disc/retina/iris, presence of any degree of vitreous hemorrhage, and tractional retinal detachment must be excluded.
• Patients that received treatment to the posterior segment for any retinal condition must be excluded. Such treatments include intravitreal injections of any kind, retinal lasers of any kind, and subtenons injections.
• The study eye has a history of previous anterior or pars plana vitrectomy for any reason must be excluded.
• The patient has a history of systemic anti-VEGF therapy or systemic corticosteroid therapy within the previous 12 months.
• The patient's macular edema is considered to be due to a cause other than diabetic macular edema.
• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, a nonretinal condition like corneal scarring or advanced optic nerve cupping from glaucoma, etc.).
• Substantial cataract that, in the opinion of the investigator, is likely decreasing visual acuity by three or more lines on its own merit (apart from the macular edema).

Sponsors & Collaborators

• Rush Eye Associates: lead

Study Sites (1)

Hospital La Carlota

Montemorelos, Nuevo León, Mexico

Location

Related Publications (1)

• Rush RB, Rush SW. Pars Plana Vitrectomy with Internal Limiting Membrane Peeling for Treatment-Naive Diabetic Macular Edema: A Prospective, Uncontrolled Pilot Study. Clin Ophthalmol. 2021 Jun 21;15:2619-2624. doi: 10.2147/OPTH.S320214. eCollection 2021.

  PMID: 34188440 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Interventions

Intravitreal Injections

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sloan Rush

  panhandle eye group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: September 4, 2018
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)