Pars Plana Vitrectomy With Internal Limiting Membrane Peeling Versus Intravitreal Ziv-Aflibercept for Treatment-Naïve Diabetic Macular Edema

• Status: Recruiting
• Trial end date: 2022-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush Eye Associates
• Collaborators: Javier Castillo, MD; Pedro Gomez, MD; Ryan Rush, MD
• Treatments: Temazepam

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Patient able and willing to provide informed consent

3. Diagnosis of diabetes mellitus (type 1 or type 2) is established.

4. 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).

5. 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.

6. On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula is present in the study eye.

7. 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).

8. 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.

Exclusion Criteria:

1. 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.

2. 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.

3. The study eye has a history of previous anterior or pars plana vitrectomy for any reason must be excluded.

4. The patient has a history of systemic anti-VEGF therapy or systemic corticosteroid therapy within the previous 12 months.

5. The patient's macular edema is considered to be due to a cause other than diabetic macular edema.

6. 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.).

7. 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).