Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection

NCT ID: NCT03453281

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2018-05-18

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, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy; Clinically Significant Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aflibercept Injection [Eylea]

Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes

Group Type: EXPERIMENTAL

Aflibercept Injection [Eylea]

Intervention Type: DRUG

Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.

Interventions

Aflibercept Injection [Eylea]

Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.

Intervention Type: DRUG

Other Intervention Names

Intravitreal Aflibercept injection; Intravitreal Eylea injection; Intravitreal anti VEGF injection; Aflibercept intravitreal injection; Eylea intravitreal injection; Anti VEGF intravitreal injection

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Martin Hertanto

Resident, Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anggun Yudantha, dr., SpM(K)

Role: PRINCIPAL_INVESTIGATOR

Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Syntia Nusanti, dr., SpM(K)

Role: PRINCIPAL_INVESTIGATOR

Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Locations

Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

17-07-0750

Identifier Type: -

Identifier Source: org_study_id