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

NCT04288232 | Completed Phase 3

• 1 other identifier: 17683
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Center-involved Diabetic Macular Edema

Keywords

anti-VEGF; intravitreal aflibercept; diabetic macular edema; Treat-and-Extend regimen

Outcome Measures

Primary Outcomes (1)

• Mean change of best corrected visual acuity (BCVA) from baseline to week 52

  BCVA is measured by ETDRS chart

  baseline to week 52

Secondary Outcomes (5)

• Mean change in central subfoveal thickness (CST) from baseline to week 52.

  baseline to week 52

• Mean/medium number of injection from baseline to week 52

  baseline to week 52

• Proportion of subjects who gained > 15 ETDRS letters from baseline to week 52

  baseline to week 52

• Proportion of subjects with > 2-step improvement in DRSS from baseline to week 52

  baseline to week 52

• Proportion of subjects demonstrating retina dry at week 20 and week 52

  week 20 and week 52

Study Arms (1)

Intravitreal aflibercept

EXPERIMENTAL

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]

Interventions

Aflibercept Injection [Eylea] DRUG

Intravitreal aflibercept Injection 2.0mg/0.05 ml

Intravitreal aflibercept

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
• History of vitreoretinal surgery and/or including scleral buckling in the study eye
• Laser photocoagulation (pan-retinal or macular) in the study eye within 90 days of Day 1
• 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)
• Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
• Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
• 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
• History of idiopathic or autoimmune uveitis in the study eye
• Cataract surgery within 90 days before Day 1 in the study eye
• Aphakia in the study eye
• Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 30 days before Day 1

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Kaohsiung Veterans General Hospital.: collaborator
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Related Publications (21)

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• Sheu SJ, Yang CH, Lai CC, Wu PC, Chen SJ. One-year outcomes of the treat-and-extend regimen using aflibercept for the treatment of diabetic macular edema. J Chin Med Assoc. 2022 Feb 1;85(2):246-251. doi: 10.1097/JCMA.0000000000000680.

  PMID: 34974510 DERIVED

MeSH Terms

Interventions

aflibercept

Study Officials

• Shih-Jen Chen, MD, PhD

  Department of Ophthalmology, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 28, 2020
• Study Start: August 31, 2015
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share