Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan

February 25, 2020 updated by: Taipei Veterans General Hospital, Taiwan

A Multicenter, Open-label, Prospective, Interventional Study to Assess the Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan

Phase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ≥ 20 years old with type 1 or 2 diabetes mellitus
  • Subjects with DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield of optical coherence tomography [OCT]) in the study eye
  • Retinal thickness as assessed by OCT above (>) 300 um in the study eye
  • BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
  • Would be able to comply with clinic visits and study-related procedures
  • Would be able to provide a signed informed consent form (ICF)

Exclusion Criteria:

  1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
  2. History of vitreoretinal surgery and/or including scleral buckling in the study eye
  3. Laser photocoagulation (pan-retinal or macular) in the study eye within 90 days of Day 1
  4. Against the background of a relevant number of previous macular laser treatments the investigator's point of view was that the subjects had no potential to benefit from laser treatments (e.g., if too many laser treatments were applied in the past)
  5. Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
  6. Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1

  7. High risk proliferative diabetic retinopathy (PDR) in the study eye upon physician's discretion

    High risk = the presence of any of the following:

    • Vitreous hemorrhage
    • New vessels on the disk >1/3 disk diameter
    • New vessels elsewhere >1/2 disk diameter
  8. History of idiopathic or autoimmune uveitis in the study eye
  9. Cataract surgery within 90 days before Day 1 in the study eye
  10. Aphakia in the study eye
  11. Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 30 days before Day 1
  12. Any other intraocular surgery within 90 days of Day 1 in the study eye
  13. Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision
  14. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
  15. Pre-retinal fibrosis involving the macula in the study eye
  16. Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
  17. Ocular inflammation including trace or above in the study eye
  18. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
  19. Filtration surgery for glaucoma in the past or likely to be needed in the future on the study eye
  20. Intraocular pressure (IOP) ≥ 25 mmHg in the study eye
  21. High myopia (≤ -6.0 diopters or axial length of ≥26.5 mm) prior to any possible refractive or cataract surgery
  22. Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
  23. Only 1 functional eye even if that eye was otherwise eligible for the study
  24. Ocular media of insufficient quality to obtain fundus and OCT images
  25. Current treatment for a serious systemic infection
  26. Administration of systemic anti-angiogenic agents within 180 days before Day 1
  27. Uncontrolled diabetes mellitus, as defined by Hemoglobin A1c; (glycosylated hemoglobin) (HbA1c)>10%.
  28. Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg while subject was sitting)
  29. History of either cerebral vascular accident and/or myocardial infarction within 180 days prior to Day 1
  30. Renal failure requiring dialysis or renal transplant
  31. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or rendered the subject at high risk for treatment complications
  32. Pregnant or breast-feeding women
  33. Sexually active men or women of childbearing potential who were unwilling to practice adequate contraception during the study were excluded (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or jelly).
  34. Allergy to fluorescein
  35. Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal aflibercept
Intravitreal injection of aflibercept 2.0mg/0.05 ml Aflibercept was administered with 5 monthly loadings followed by treat-and-extend with a 4-week interval increment/decrement with maxima cap at 12 weeks to visual/anatomic stability.
Drug: Aflibercept Injection [Eylea]
Intravitreal aflibercept Injection 2.0mg/0.05 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change of best corrected visual acuity (BCVA) from baseline to week 52
Time Frame: baseline to week 52
BCVA is measured by ETDRS chart
baseline to week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in central subfoveal thickness (CST) from baseline to week 52.
Time Frame: baseline to week 52
Central subfoveal thickness (CST) as assessed by OCT
baseline to week 52
Mean/medium number of injection from baseline to week 52
Time Frame: baseline to week 52
Mean/medium number of intravitreal aflibercept injection from baseline to week 52
baseline to week 52
Proportion of subjects who gained > 15 ETDRS letters from baseline to week 52
Time Frame: baseline to week 52
BCVA is measured by ETDRS chart
baseline to week 52
Proportion of subjects with > 2-step improvement in DRSS from baseline to week 52
Time Frame: baseline to week 52
DR level as assessed by diabetic retinopathy severity score (DRSS)
baseline to week 52
Proportion of subjects demonstrating retina dry at week 20 and week 52
Time Frame: week 20 and week 52
Retina dry as assessed by OCT
week 20 and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

National Taiwan University Hospital
Chang Gung Memorial Hospital
Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Shih-Jen Chen, MD, PhD, Department of Ophthalmology, Taipei Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2015

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

February 9, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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