The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy
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|ClinicalTrials.gov Identifier: NCT03006081|
Recruitment Status : Unknown
Verified December 2016 by Young Hee Yoon, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: Intravitreal Aflibercept injection||Phase 2|
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 various retinal vascular diseases including diabetic retinopathy and retinal vein occlusion. Silva et al revealed that retinal nonperfusion area was correlated highly with diabetic retinopathy severity in their recent paper. It should be clarified that retinal nonperfusion is not synonymous with retinal ischemia, which implies tissue hypoxia, but is a useful surrogate.
Retinal nonperfusion has known to be associated with the production of vascular endothelial factor (VEGF). Recently, Campochiaro et al reported that neutralization of VEGF using ranibizumab improved macular edema and reversed the worsening of retinal nonperfusion in patients with retinal vein occlusion and diabetic macular edema. The precise mechanism for improved perfusion in the VEGF treated eye is uncertain. The authors suggested that VEGF exacerbates retinal ischemia by increasing leukostasis, and intravitreal anti-VEGF agents may break the feedback loop, allowing reperfusion to occur. There might be a portion of circulation that is closed but not permanently, and this reversible closure is modulated by VEGF.
The study by Campochiaro et al, however, was limited in that they reviewed retinal nonperfusion within a template consisting of the Early Treatment Diabetic Retinopathy subfields mainly confined to posterior pole of the fundus. Wide-field retinal imaging is an imaging technique that allows a view of almost 200° of the fundus in a single image. It has been well shown that wide-field scans allow the detection of peripheral pathology that may be missed on 75 degrees of achieved by montaging the Early Treatment Diabetic Retinopathy Study 7-standard fields.
To investigators knowledge, there has been no previous study evaluating the longitudinal change of retinal nonperfusion after aflibercept treatment in a larger area of the retina by taking advantage of the 200° field of view in 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Patients With Diabetic Retinopathy|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: 2mg intravitreal aflibercept injection
2mg intravitreal aflibercept (Eylea) injection at baseline, 1M, 2M, 3M, 4M, and 5M
Drug: Intravitreal Aflibercept injection
Six number of injections at baseline, 1M, 2M, 3M, 4M, and 5M
Other Name: Eylea
- Improvement of retinal nonperfusion [ Time Frame: 1 year ]Mean changes (%) of retinal nonperfusion (Ischemic index) from baseline
- progression of diabetic retinopathy to proliferative diabetic retinopathy (PDR) [ Time Frame: 1 year ]Number of patients who receive rescue treatment due to PDR and time to rescue treatment due to PDR
- development of diabetic macular edema [ Time Frame: 1 year ]Number of patients who receive rescue treatment due to DME and time to rescue treatment due to DME
- Factors associated with the progression of retinal nonperfusion 1 (Functional) [ Time Frame: 1 year ]- Visual acuity parameters: Mean changes of BCVA from baseline at every 3 month visit The proportion of subjects with gaining / losing ≥ 15letters or more in BCVA
- Factors associated with the progression of retinal nonperfusion 2 (Anatomical) [ Time Frame: 1 year ]- Optical coherence tomography (OCT) parameters: Mean changes of Central Retinal Thickness (CRT) from baseline at every 3 month visit Mean changes of Central Retinal Volume from baseline at every 3 month visit Mean change subfoveal choroidal thickness (SFChT) from baseline at every 3 month visit
- Factors associated with the progression of retinal nonperfusion 3 (Anatomical) [ Time Frame: 1year ]- Fluorescein angiography (FA) parameters: Baselinenonperfusion area(Ischemic index) at posterior and peripheral retina Baseline degree of vascular leakage at posterior and peripheral retina
- Safety outcome; Adverse effect of intravitreal aflibercept (Eylea) injection [ Time Frame: 1 year ]Ocular and systemic adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006081
|Contact: Yoon Jeon Kim, MDemail@example.com|
|Korea, Republic of|
|Asan medical center||Recruiting|
|Olympicro 43 gil 88, Seoul, Korea, Republic of, 05505|
|Contact: Young Hee Yoon, MD 82-2-3010-3680|
|Principal Investigator:||Young Hee Yoon||Asan Medical Center|