Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy

UMIN ID: UMIN000016036

Registered date:01/01/2015

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: Diabetic macular edema
• Date of first enrollment: 2015/02/05
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Clinicians should inject aflibercept (EYLEA) 2 mg dosed in the eye monthly for 5 initial months and then inject monthly until 12 months after first administration according to following re-injection criteria.
< re-injection criteria >
Clinicians decide additional injection of aflibercept (EYLEA) 2 mg until under 250um in central macular thickness or below 0 in best-corrected logMAR visual acuity.

Outcome(s)

• Primary Outcome: Change of central macular thickness measured by OCT from baseline to month 6

Secondary Outcome

･Change of best-corrected visual acuity from baseline to month 6
･Proportion of patients with 2-line improvement in best-corrected visual acuity from baseline to month 6
･Proportion of patients with 20% improvement in central macular thickness measured by OCT from baseline to month 6
･Change of retinal sensitivity measured by humphrey (10-2) from baseline to month 6
･Change of subjective symptom by National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25) from baseline to month 6
･Adverse event at moth 6

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Include criteria

1) Vitrectomized eye with recurrent or prolonged diabetic macular edema more than 6 months after vitrectomy
( more than 300um in central macular thickness measured by OCT retinal map)
2) 0.2-1.2 in best-corrected logMAR visual acuity
3) Type 1 or Type 2 diabetes mellitus
(20 years and older)
4) Vitrectomy was performed for not proliferative diabetic retinopathy but for diabetic macular edema
5) Written informed consent was obtained

Exclude criteria

1) Use of any anti VEGF therapy for candidate eyes after vitrectomy
2) Use of any steroid therapy (except for eye drop) for candidate eyes within 3 months prior to initial injection
3) Intraocular,periocular inflammation or infection in candidate eye
4) Allergy history for drug used in this trial
5) Women who are pregnant or breast feeding or who are capable of becoming pregnant
6) Focal, grid laser photocoagulation within 3 months prior to initial injection
7) Proliferative diabetic retinopathy such as vitreous hemorrhage,preretinal hemorrhage,neovascularization, proliferative membrane,tractional retinal detachment
8) Some of optic disc atrophy
9) Cataract that would interfere with required fundus examinations, fundus photographs or OCT
10) Cataract surgery within 6 months prior to initial injection
11) Systematic diseases( sever heart failure, stroke, blood disease, malignant tumor)
12) History of systematic steroids treatment
13) Sever renal failure (serum creatinine>2.0 mg/dL)
14)Presence of uncontrolled hypertension
(systolic>180mmHg,diastolic>110mmHg)
15) HbA1c>10%
16) Considered unsuitable candidate by clinicians

Related Information

• Primary Sponsor: Kyushu university
• Source(s) of Monetary Support: Bayer Yakuhin Ltd.