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Clinical Trials List

Protocol Number20968

2020-05-01 - 2021-08-20

Phase III

Not yet recruiting5

Recruiting1

ICD-10H35.32

Exudative age-related macular degeneration

ICD-9362.52

Exudative senile macular degeneration

To determine if treatment with aflibercept 8 mg (HD) at intervals of 12 or 16 weeks provides non-inferior BCVA change compared to aflibercept 2 mg every 8 weeks in participants with nAMD

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Bayer AG.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Shih-Jen Chen Division of Ophthalmology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wei-Chi WU Division of Ophthalmology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 鄭成國 Division of Ophthalmology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator San-Ni Chen Division of Ophthalmology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHANG-HAO YANG Division of Ophthalmology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shwu-Jiuan Sheu Division of Ophthalmology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

NAMD

Objectives

To determine if treatment with aflibercept 8 mg (HD) at intervals of 12 or 16 weeks provides non-inferior BCVA change compared to aflibercept 2 mg every 8 weeks in participants with nAMD

Test Drug

BAY 86-5321

Active Ingredient

aflibercept

Dosage Form

intravitreal injection
intravitreal injection

Dosage

40
114.3

Endpoints

Change from baseline in BCVA measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 48

Inclution Criteria

Signed informed consent must be obtained prior to participation in the study.
• Patients ≥ 18 years of age at Screening.Participant cooperation sufficient for adequate fundus photographs and retinal images.
• Patients diagnosed with diabetes mellitus (DM) type 1 or 2, and HbA1c ≤ 12% at Screening.
• Any medication administered for the management of diabetes should be stable within 3 months prior to randomization and is expected to remain stable during the course of the study, as medically acceptable.
• PDR in the study eye as assessed by the investigator using standard or wide-field color fundus photography (CFP) and fluorescein angiography (FA), with no evidence of previous PRP, and that requires treatment with either anti-Vascular Endothelial Growth Factor (VEGF) agent or PRP in the opinion of the investigator.
• BCVA ≥ 34 ETDRS letters (Snellen equivalent 20/200) in the study eye at Screening and Baseline.

Exclusion Criteria

Concomitant conditions or ocular disorders in the study eye at Screening or Baseline as well as planned medical/surgical intervention during the first 54-week study period that could compromise functional or structural response to study treatment, in the opinion of the investigator
• Presence of center-involved DME in the study eye at Screening or Baseline, as assessed by the investigator.
• Other ocular conditions in the study eye:
• Any active intraocular or periocular infection or active intraocular inflammation at Screening or Baseline.
• Uncontrolled glaucoma in defined as intraocular pressure (IOP) > 25 mmHg despite treatment with IOP lowering medication, or according to investigator’s judgment, at Screening or Baseline.
• Iris or anterior chamber angle neovascularization,or neovascular glaucoma.
• Moderate or dense pre-retinal or vitreous hemorrhage that prevents clear visualization of the macular and / or optic disc or prevents PRP treatment.at Baseline.
• Significant fibrovascular vitreoretinal proliferation or tractional retinal detachment.
• Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions for which treatment or surgery may improve VA).
• Ocular treatments in the study eye:
• PRP any time prior to Baseline.
• Intravitreal anti-VEGF treatment within six months prior to Baseline.
• Vitreoretinal surgery at any time prior to Baseline or anticipated need for vitreoretinal surgery within the next 12 months.Laser treatment of the macula within 3 months prior to Baseline.
• Treatment with fluocinolone acetonide intravitreal implant at any time prior to Baseline. Other intraocular or periocular corticosteroid injection within 6 months prior to Baseline.
• Intraocular surgery within 3 months prior to Baseline or anticipated need for cataract extraction within the next 12 months.
• Systemic conditions or treatments: stroke or myocardial infarction during the 6-month period prior to baseline, end stage renal disease requiring dialysis or renal transplant, systemic anti-VEGF therapy at any time.

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    966 participants

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