Status:
COMPLETED
Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Bayer
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, a...
Eligibility Criteria
Inclusion
- Minimum age of 18 y.o.
- Diagnosed with Type 1 or 2 Diabetes Mellitus
- Have either one of mild non-proliferative diabetic retinopathy (NPDR), moderate NPDR, severe NPDR, or Proliferative Diabetic Retinopathy with clinically significant macular edema according to Early Treatment for Diabetic Retinopathy Study (ETDRS) criteria
- Best corrected visual acuity between one meter finger counting to 6/12 (ETDRS chart)
- Minimum Central Macular Thickness by Optical Coherence Tomography examination of 250 um
- Willing to participate and sign the informed consent.
Exclusion
- Ongoing pregnancy or planning to be pregnant for the next 6 months.
- Media opacity (e.g. corneal scar, corneal edema, cataract, vitreous hemorrhage) which make macular OCT not possible
- History of intraocular surgery in the last 6 months
- Vitreoretinal surface disorders e.g. epiretinal membrane, vitreoretinal traction
- History of panretinal laser photocoagulation in the last 6 months
- Presence of iris neovascularization
- History of eye trauma
- HbA1c level \> 10,0 %
- Any other contraindication(s) for intravitreal anti VEGF injection.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03453281
Start Date
October 10 2017
End Date
May 18 2018
Last Update
July 12 2018
Active Locations (1)
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1
Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
Jakarta Pusat, DKI Jakarta, Indonesia, 10430