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

Phase 4

• Conditions: Diabetic macular edema

• Registration Number: JPRN-UMIN000016036
• Lead Sponsor: Kyushu university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Open public recruiting
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of central macular thickness measured by OCT from baseline to month 6

Secondary Outcome Measures

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