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

NCT03006081 | Completed Phase 2 DMC

• 1 other identifier: FLOW_001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy

Keywords

Retinal nonperfusion; Aflibercept

Outcome Measures

Primary Outcomes (1)

• Improvement of retinal nonperfusion

  Mean changes (%) of retinal nonperfusion (Ischemic index) from baseline

  1 year

Secondary Outcomes (5)

• progression of diabetic retinopathy to proliferative diabetic retinopathy (PDR)

  1 year

• development of diabetic macular edema

  1 year

• Factors associated with the progression of retinal nonperfusion 1 (Functional)

  1 year

• Factors associated with the progression of retinal nonperfusion 2 (Anatomical)

  1 year

• Factors associated with the progression of retinal nonperfusion 3 (Anatomical)

  1year

Other Outcomes (1)

• Safety outcome; Adverse effect of intravitreal aflibercept (Eylea) injection

  1 year

Study Arms (1)

2mg intravitreal aflibercept injection

EXPERIMENTAL

2mg intravitreal aflibercept (Eylea) injection at baseline, 1M, 2M, 3M, 4M, and 5M

Drug: Intravitreal Aflibercept injection

Interventions

Intravitreal Aflibercept injection DRUG

Six number of injections at baseline, 1M, 2M, 3M, 4M, and 5M

Also known as: Eylea

2mg intravitreal aflibercept injection

Eligibility Criteria

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

You may qualify if:

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• Patients diagnosed as nonproliferative diabetic retinopathy with retinal nonperfusion (Ischemic index \>20%) Severe nonproliferative diabetic retinopathy - Early proliferative diabetic retinopathy
• Willing and able to comply with clinic visits and study-related procedures
• Provide a signed informed consent form

You may not qualify if:

• A subject who meets any of the following criteria will be excluded from the study.
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• 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
• Presence of rubeosis (neovascularization of the iris or the angle) in the study eye
• Any current or history of retinal diseases that affects visual acuity in the study eye
• Previous treatment of panretinal photocoagulation
• Previous treatment with anti-VEGF in study eye within 6 months before Visit 1
• Previous treatment with intraocular or periocular corticosteroids in the study eye within 6 months before Visit 1
• Previous history of intraocular surgery other than cataract surgery in the study eye
• Cataract surgery within 3 months before Visit 1 in the study eye
• Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 1 month before Visit 1
• Aphakia in the study eye
• 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
• Presence of a visually significant cataract in the study eye
• BCVA score \< 34 letters in the fellow eye

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, Seoul, 05505, South Korea

Location

Related Publications (4)

• Silva PS, Dela Cruz AJ, Ledesma MG, van Hemert J, Radwan A, Cavallerano JD, Aiello LM, Sun JK, Aiello LP. Diabetic Retinopathy Severity and Peripheral Lesions Are Associated with Nonperfusion on Ultrawide Field Angiography. Ophthalmology. 2015 Dec;122(12):2465-72. doi: 10.1016/j.ophtha.2015.07.034. Epub 2015 Sep 6.

  PMID: 26350546 BACKGROUND

• Campochiaro PA, Wykoff CC, Shapiro H, Rubio RG, Ehrlich JS. Neutralization of vascular endothelial growth factor slows progression of retinal nonperfusion in patients with diabetic macular edema. Ophthalmology. 2014 Sep;121(9):1783-9. doi: 10.1016/j.ophtha.2014.03.021. Epub 2014 Apr 24.

  PMID: 24768239 BACKGROUND

• Silva PS, Cavallerano JD, Haddad NM, Kwak H, Dyer KH, Omar AF, Shikari H, Aiello LM, Sun JK, Aiello LP. Peripheral Lesions Identified on Ultrawide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years. Ophthalmology. 2015 May;122(5):949-56. doi: 10.1016/j.ophtha.2015.01.008. Epub 2015 Feb 19.

  PMID: 25704318 BACKGROUND

• Kim YJ, Yeo JH, Son G, Kang H, Sung YS, Lee JY, Kim JG, Yoon YH. Efficacy of intravitreal AFlibercept injection For Improvement of retinal Nonperfusion In diabeTic retinopathY (AFFINITY study). BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001616. doi: 10.1136/bmjdrc-2020-001616.

  PMID: 33077475 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Study Officials

• Young Hee Yoon

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 30, 2016
• Study Start: April 14, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: December 2, 2025

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)