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Trial record 9 of 260 for:    macular degeneration | Open Studies

Study of DS-7080a for the Treatment of Neovascular Age-Related Macular Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02530918
First received: August 17, 2015
Last updated: February 20, 2017
Last verified: February 2017

August 17, 2015
February 20, 2017
July 2015
March 2017   (Final data collection date for primary outcome measure)
  • Number and severity of adverse events [ Time Frame: 12 weeks ]
    To count the number and severity of treatment emergent adverse events (TEAEs) during the 12 week course of treatment.
  • Best Corrected Visual Acuity (BCVA) score [ Time Frame: 12 weeks ]
    Visual acuity of both eyes will be assessed at all study visits using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
Same as current
Complete list of historical versions of study NCT02530918 on ClinicalTrials.gov Archive Site
  • DS-7080a reduction in retinal thickness and volume [ Time Frame: 12 weeks ]
    anti-neovascularization impact based on a reduction in retinal thickness and volume, as assessed by spectral domain optical coherence tomography (SD-OCT)
  • DS-7080a reduction in retinal leakage [ Time Frame: 12 weeks ]
    anti-neovascularization impact based on a reduction in retinal leakage, as assessed by fluorescein angiography (FA)
  • DS-7080a plasma concentrations [ Time Frame: 16 weeks ]
    Analysis of plasma samples for DS-7080a concentration determinations will be performed.
Same as current
Not Provided
Not Provided
 
Study of DS-7080a for the Treatment of Neovascular Age-Related Macular Degeneration
PHASE I DOSE ESCALATION AND EXPANSION STUDY OF DS-7080a IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with neovascular AMD either alone or in combination with ranibizumab. This study is organized into 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, subjects will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner. In Part 2, subjects will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Neovascular Age-Related Macular Degeneration
  • Drug: DS-7080a
    1.0, 2.0, or 4.0 mg by intravitreal (IVT) injection of a 50 μL of solution administered every 4 weeks for 12 weeks.
  • Drug: Ranibizumab
    0.5 mg by IVT injection of a 50μL of solution administered every 4 weeks for 12 weeks.
    Other Name: Lucentis
  • Experimental: Part 1 DS-7080a dose escalation
    3 sequential ascending dose levels (1.0, 2.0, 4.0 mg) by intravitreal (IVT) injection of a 50 μL of solution.
    Intervention: Drug: DS-7080a
  • Experimental: Part 2 DS-7080a
    Specific dose of DS-7080a will be determined in Part 1 and will be either the Maximum Tolerated Dose (MTD) or 4.0 mg by IVT injection of a 50 μL solution.
    Intervention: Drug: DS-7080a
  • Active Comparator: Part 2 ranibizumab
    Ranibizumab (Lucentis) 0.5 mg by IVT injection of a 50 μL.
    Intervention: Drug: Ranibizumab
  • Experimental: Part 2 DS-7080a and ramibizumab

    Specific dose of DS-7080a will be determined in Part 1 and administered by IVT injection of a 50 μL of solution.

    Ranibizumab (Lucentis) 0.5 mg by IVT injection of a 50 μL.

    Interventions:
    • Drug: DS-7080a
    • Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
June 2017
March 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 50 years of age;
  • Active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD);
  • CNV ≥ 50% of total lesion size in study eye;
  • Central sub-field thickness > 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye;
  • For Part 1 only, ETDRS BCVA letter score ≤ 49 (approximately 20/100 or worse) in the study eye and ≥ 49 (approximately 20/100 or better) in the fellow eye at Screening Visit;
  • For Part 2 only, ETDRS BCVA letter score of 78 to 25 (approximately 20/32 to 20/320) in the study eye.

Exclusion Criteria:

  • For Part 1 only, any ocular (in the study eye) or systemic treatment or surgery for neovascular AMD within 4 weeks of Baseline Visit, except dietary supplements or vitamins;
  • For Part 2 only, any prior therapy in the study eye within 3 months of Baseline Visit, except dietary supplements or vitamins;
  • Use of any long acting steroids, either systemically or intraocularly, within 6 months of Baseline Visit;
  • Total lesion size > 12 disc areas (30.5 mm2) in the study eye;
  • For Part 1 only, a subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye;
  • For Part 1 only, scarring or fibrosis, making up >50% of total lesion or involving the center of the fovea in the study eye;
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye;
  • History of any vitreous hemorrhage within 4 weeks prior to Screening Visit in the study eye;
  • The presence of causes of CNV other than AMD;
  • Prior vitrectomy in the study eye;
  • History of retinal detachment or treatment or surgery for retinal detachment in the study eye;
  • Any history of a full thickness macular hole in the study eye;
  • Any intraocular or periocular surgery within 3 months of Baseline Visit on the study eye, except lid surgery;
  • Uncontrolled glaucoma in the study eye;
  • Active intraocular inflammation or periocular infection in either eye;
  • Any history of uveitis in either eye of scleromalacia in either eye;
  • Aphakia or pseudophakia in the study eye;
  • Previous therapeutic radiation in the region of the study eye;
  • History of corneal transplant or corneal dystrophy in the study eye;
  • Significant media opacities in the study eye (e.g. cataract) that could require either medical or surgical intervention during the study period;
  • Women who are pregnant, breastfeeding, or of childbearing potential and unwilling to practice two measures of adequate contraception throughout the study.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact: Sunita Saigal 978-685-8900 Ext. 9477 ssaigal@oraclinical.com
United States
 
 
NCT02530918
DS7080-A-U101
No
Not Provided
Not Provided
Not Provided
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP