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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03453281
Date of registration:	26/02/2018
Prospective Registration:	No
Primary sponsor:	Indonesia University
Public title:	Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection
Scientific title:	Central Macular Thickness, Macular Electroretinogram, and Visual Acuity in Patients With Diabetic Macular Edema After Intravitreal Aflibercept Injection. A One Month Pre-Post Intervention Follow Up Study
Date of first enrolment:	October 10, 2017
Target sample size:	36
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03453281
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Indonesia

Contacts

Name:	Anggun Yudantha, dr., SpM(K)
Address:
Telephone:
Email:
Affiliation:	Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Name:	Syntia Nusanti, dr., SpM(K)
Address:
Telephone:
Email:
Affiliation:	Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Retinopathy

Clinically Significant Macular Edema

Diabetic Macular Edema

Intervention(s)

Drug: Aflibercept Injection [Eylea]

Primary Outcome(s)

Central macular thickness [Time Frame: One month after intravitreal Aflibercept injection]

Secondary Outcome(s)

Uncorrected visual acuity [Time Frame: One month after intravitreal Aflibercept injection]

Uncorrected visual acuity [Time Frame: One week after intravitreal Aflibercept injection]

Amplitude of P1 wave [Time Frame: One week after intravitreal Aflibercept injection]

Uncorrected visual acuity (number of letters) [Time Frame: One month after intravitreal Aflibercept injection]

Best corrected visual acuity [Time Frame: One week after intravitreal Aflibercept injection]

Best corrected visual acuity (number of letters) [Time Frame: One week after intravitreal Aflibercept injection]

Amplitude of N1 wave [Time Frame: One month after intravitreal Aflibercept injection]

Amplitude of N1 wave [Time Frame: One week after intravitreal Aflibercept injection]

Best corrected visual acuity (number of letters) [Time Frame: One month after intravitreal Aflibercept injection]

Implisit time of N1 wave [Time Frame: One month after intravitreal Aflibercept injection]

Uncorrected visual acuity (number of letters) [Time Frame: One week after intravitreal Aflibercept injection]

Amplitude of N2 wave [Time Frame: One month after intravitreal Aflibercept injection]

Implisit time of N2 wave [Time Frame: One month after intravitreal Aflibercept injection]

Implisit time of P1 wave [Time Frame: One month after intravitreal Aflibercept injection]

Implisit time of P1 wave [Time Frame: One week after intravitreal Aflibercept injection]

Amplitude of N2 wave [Time Frame: One week after intravitreal Aflibercept injection]

Central macular thickness [Time Frame: One week after intravitreal Aflibercept injection]

Amplitude of P1 wave [Time Frame: One month after intravitreal Aflibercept injection]

Best corrected visual acuity [Time Frame: One month after intravitreal Aflibercept injection]

Implisit time of N1 wave [Time Frame: One week after intravitreal Aflibercept injection]

Implisit time of N2 wave [Time Frame: One week after intravitreal Aflibercept injection]

Secondary ID(s)

17-07-0750

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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