The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Retinal nonperfusion drives vision-threatening complications such as pathological neovascularization, which can lead to neovascular glaucoma, vitreous hemorrhage, or tractional retinal detachments and macular edema in diabetic retinopathy. Thus, decreasing nonperfusion area with aid of anti-VEGF agents might be a useful way to prevent deteriorating course of diabetic retinopathy. The main purpose of this study is to determine the efficacy of intravitreal aflibercept injection in improvement of retinal nonperfusion and identify associated factors in patients with nonproliferative diabetic retinopathy with moderate retinal nonperfusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• A subject must meet the following criteria to be eligible for inclusion in the study:

1. Adults ≥ 18 years with type 1 or 2 diabetes mellitus

2. Patients diagnosed as nonproliferative diabetic retinopathy with retinal nonperfusion (Ischemic index >20%) Severe nonproliferative diabetic retinopathy - Early proliferative diabetic retinopathy

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide a signed informed consent form

Exclusion Criteria:

• A subject who meets any of the following criteria will be excluded from the study.

1. Systemic exclusion criteria 1. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to baseline or anticipated need for hemodialysis, peritoneal dialysis at any time during the study 2. Acute cardiovascular events (acute myocardiac infarction and/or cerebral infarction) within 1 year before Visit 1 3. Blood HbA1c level greater than 12% at Visit 0

2. Ocular exclusion criteria

1. Diabetic macular edema involving the center of the macula (Defined as the area of the center subfield of OCT, Heidelberg Spectralis: ≥305 in women; ≥320 in men) in the study eye

2. Presence of rubeosis (neovascularization of the iris or the angle) in the study eye

3. Any current or history of retinal diseases that affects visual acuity in the study eye

4. Previous treatment of panretinal photocoagulation

5. Previous treatment with anti-VEGF in study eye within 6 months before Visit 1

6. Previous treatment with intraocular or periocular corticosteroids in the study eye within 6 months before Visit 1

7. Previous history of intraocular surgery other than cataract surgery in the study eye

8. Cataract surgery within 3 months before Visit 1 in the study eye

9. Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 1 month before Visit 1

10. Aphakia in the study eye

11. Elevated intraocular pressure (≥ 22 mmHg) in spite of using topical IOP lowering agents at Visit 1 or a diagnosis of glaucoma (Visual field defect corresponding to glaucomatous optic neuropathy) in the study eye

12. Presence of a visually significant cataract in the study eye

13. BCVA score < 34 letters in the fellow eye

14. Hypersensitivity to aflibercept

15. Ocular or periocular infection

16. Active intraocular inflammation