A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of treatment resistant diabetic macular oedema

Andrew Chang0 sites50 target enrollmentDecember 15, 2014

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Andrew Chang

•\*Ability to provide informed consent and complete study assessments
•\*Age 18 years or older
•\*Macular oedema involving in central macula secondary to type 1 or type 2 diabetic mellitus in study eye.
•\*Best corrected baseline visual acuity between 85\-34 letters on early treatment in diabetic retinopathy study (ETDRS) chart (Snellen equivalent 6/6 to 6/60\) on study eye
•\*Presence of central diabetic macular odema (DMO) \>300 microns on spectral domain optical coherence tomography (SD\-OCT) after at least 4 anti\-VEGF (vascular endothelial growth factor) treatments within minimum of 6 months
•\*Documentation of the presence of macular oedema at least 30 days since last treatment.

•\*Pregnancy or lactation
•\*Premenopausal women not using contraception
•\*Prior anti\-VEGF injection in the study eye within 30 days of baseline
•\*Prior treatment with triamcinolone in the study eye within 3 months of baseline
•\*Intraocular surgery in the study eye within 2 months of baseline
•\*Macular laser within 2 months or previous laser scar would prevent the improvement of macular function
•\*Prior vitrectomy in the study eye within 3 months of baseline
•\*Current vitreous haemorrhage or inflammation in the study eye
•\*Uncontrolled glaucoma in the study eye. Intraocular pressure (IOP) greater than 30mmHg on maximal medical therapy.
•\*Active proliferative diabetic retinopathy (PDR) in the study eye.