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

NCT03453281 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 17-07-0750
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Aflibercept; Diabetic Macular Edema; Electroretinogram; Central Macular Thickness; ETDRS

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

  Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany \[in µm\]

  One month after intravitreal Aflibercept injection

Secondary Outcomes (21)

• Central macular thickness

  One week after intravitreal Aflibercept injection

• Amplitude of P1 wave

  One week after intravitreal Aflibercept injection

• Amplitude of P1 wave

  One month after intravitreal Aflibercept injection

• Amplitude of N1 wave

  One week after intravitreal Aflibercept injection

• Amplitude of N1 wave

  One month after intravitreal Aflibercept injection

Study Arms (1)

Aflibercept Injection [Eylea]

EXPERIMENTAL

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

Drug: Aflibercept Injection [Eylea]

Interventions

Aflibercept Injection [Eylea] DRUG

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

Also known as: Intravitreal Aflibercept injection, Intravitreal Eylea injection, Intravitreal anti VEGF injection, Aflibercept intravitreal injection, Eylea intravitreal injection, Anti VEGF intravitreal injection

Aflibercept Injection [Eylea]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead
• Bayer: collaborator

Study Sites (1)

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Anggun Yudantha, dr., SpM(K)

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

  PRINCIPAL INVESTIGATOR

• Syntia Nusanti, dr., SpM(K)

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia

Model Details: Every subject was given the same treatment (intravitreal Aflibercept injection).

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: October 10, 2017
• Primary Completion: April 9, 2018
• Study Completion: May 18, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

ID (1)