Visual functions in patients with diabetic macular edema following aflibercept therapy.

JRCT ID: jRCTs031180161

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic Macular Edema
• Date of first enrollment: 21/06/2016
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Loading Phase
Aflibercept will be administered by 3-5 consecutive monthly intravitreal injections.
If a subject does not meet the Re-injection criteria, the subject will proceed to the Treat and Extend (T&E) phase after 3 injections (month 2).
After 5 injections (month 4), all patiets will proceed to the T&E phase.

Measurement of results
BCVA with the Landolt chart at every visit
Central macular thickness (CMT) by Spectral Domain-OCT at every visit
Contrast sensitivity by CSV-1000LV chart at every visit
Vision-related quality of life (VR-QOL) with the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25) at pretreatment, 3, 6, and 12 month
Adverse eventsr/ serious adverse events

Outcome(s)

• Primary Outcome: Contrast sensitivity from baseline to 12 month

Secondary Outcome

BCVA
Central macular thickness(CMT)
Vision-related quality of life (VR-QOL)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

A subject must meet the following criteria to be eligible for inclusion in the study
(1) Adults more than 20 years with type 1 or 2 diabetes mellitus
(2) Subjects with DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield of OCT) in the study eye
(3) Decrease in vision determined to be primarily the result of DME in the study eye
(4) BCVA (ETDRS) more than 24 letters (20/320)
(5) Central retinal thickness (CRT) as assessed by OCT of more than 300 in the study eye
(6) Willing and able to comply with clinic visits and study related procedures

Exclude criteria

A subject who meets any of the following criteria will be excluded from the study:
(1)The study eye is better than fellow eye
(2)History of vitreoretinal surgery (including annular concluded surgery)
(3)Laser photocoagulation (panretinal or macular) in the study eye within 90 days before Day 1
(4)More than 1 treatment with Direct laser/grid laser
(5)Previous use of intraocular or periocular corticosteroids in the study eye within 120 days
(6)Previous treatment with anti-angiogenic drugs in either eye within 90 days
(7)Proliferative diabetic retinopathy (PDR) in the study eye
(8)History of idiopathic or autoimmune uveitis in the study eye
(9)Any intraocular surgery in the study eye within 90 days before Day 1
(10)Aphakia in the study eye
(11)Vitreomacular traction that is thought to affect central vision in the study eye
(12)Current iris neovascularization, vitreoushemorrhage, or tractional retinal detachment in the study eye
(13)Pre-retinal fibrosis in the study eye
(14)Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
(15)History of endophthalmitis in the study eye
(16)Infectious blepharitis, keratitis,scleritis or conjunctivitis in either eye
(17)Uncontrolled graucoma, filtration surgery for glaucoma or likely to be needed in the future on the study eye
(18)High intraocular pressure in the study eye (> 25 mmHg)
(19)High myopia (greater than or equal to -8D)
(20)History of disease that can result in decreased visual acuity (ex. Retinal vascular occlusion, retinal detachment, macular hole or macular neovascularization, except for DME)
(21)Only one functional eye
(22)Ocular media insufficient to obtain fundus and OCT images in the study eye
(23)Serious systemic infection
(24)Administration of systemic anti-angiogenic agents within 180 days before day 1
(25)Uncontrolled blood pressure (systolic >160 mmHg or diastolic >95 mmHg)
(26)Uncontrolled diabetes mellitus (HbA1c>12.0%)
(27)History of cerebrovascular accident and/or Myocardial infarction within 180 days before day 1
(28)Renal failure requiring dialysis or renal transplant
(29)Systemic disease patients who need treatment that may affect outcomes
(30)Pregnant or breast-feeding women
(31)Female subjects wish for a pregnancy within the intended treatment period
(32)Allergy to fluorescein
(33)Hypersensitive to aflibercept
(34)Previous participation in any studies of investigational drugs within 30 days preceding Day 1
(35)Subjects who judged by a investigator to be inappropriate for the study

Related Information

• Primary Sponsor: Okamoto Fumiki
• Source(s) of Monetary Support: Bayer