Study of DS-7080a for the Treatment of Macular Degeneration

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Daiichi Sankyo
Study ID
NCT02530918
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DS-7080a — DRUG
    1.0, 2.0, or 4.0 mg administered by a 50 μL intravitreal (IVT) injection of solution
  • Ranibizumab — DRUG
    0.3 mg or 0.5 mg administered by a 50 μL IVT injection of solution

Study Details

The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in combination with ranibizumab. This study is organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in AMD participants, and Part 3 Dose Expansion in DME participants. In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner with the main purpose to determine the recommended dose. In Part 2, participants 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). In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3 times: on Baseline/Day 1, Day 29, and Day 57. Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day treatment period, and a 28-day follow-up period.

Key Dates

First listed
Aug 21, 2015
Start date
Jul 31, 2015
Status verified
May 2018
Primary completion
Jan 2, 2018
Completion
Jan 2, 2018

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 DS-7080a dose escalation
    3 sequential ascending dose levels (1.0, 2.0, 4.0 mg), every 4 weeks for 12 weeks
  • Experimental: Part 2 DS-7080a
    Specific dose (either the maximum tolerated dose or 4.0 mg) of DS-7080a determined in Part 1, every 4 weeks for 12 weeks
  • Active Comparator: Part 2 ranibizumab
    Ranibizumab 0.5 mg, every 4 weeks for 12 weeks
  • Experimental: Part 2 DS-7080a and ranibizumab
    Specific dose of DS-7080a determined in Part 1 and ranibizumab 0.5 mg, every 4 weeks for 12 weeks
  • Experimental: Part 3 DS-7080a
    Specific dose of DS-7080a determined in Part 1, every 4 weeks for 12 weeks
  • Experimental: Part 3 ranibizumab
    Ranibizumab 0.3 mg, every 4 weeks for 12 weeks

Primary Outcome Measure

Number of participants experiencing any treatment-emergent adverse event (TEAE) [ Time Frame: 16 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
-PhoenixArizona85014-
-ArcadiaCalifornia91007-
-Beverly HillsCalifornia90211-
-Palm DesertCalifornia92260-
-Fort MyersFlorida33912-
-BaltimoreMaryland21237-
-BostonMassachusetts02114-
-OmahaNebraska68105-
-AbileneTexas79606-
-AustinTexas78705-
-San AntonioTexas78240-
-SilverdaleWashington98383-

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