Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Allergan
Study ID
NCT01397409
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • AGN-150998 — DRUG
    AGN-150998 Intravitreal injection.
  • ranibizumab — DRUG
    Ranibizumab 0.5 mg given by intravitreal injection.
  • Sham Injection — OTHER
    Stage 3: Sham injection at Weeks 12 and 16.

Study Details

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

Key Dates

First listed
Jul 19, 2011
Start date
Sep 1, 2011
Status verified
Apr 2019
Primary completion
Mar 31, 2014
Completion
Apr 30, 2014

Study Design

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

Arms

  • Experimental: Stage 1: AGN-150998 4.2 mg
    Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.
  • Experimental: Stage 1: AGN-150998 3.0 mg
    Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
  • Experimental: Stage 1: AGN-150998 2.0 mg
    Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
  • Experimental: Stage 1: AGN-150998 1.0 mg
    Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
  • Experimental: Stage 2: AGN-150998 4.2 mg
    Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
  • Experimental: Stage 2: AGN-150998 3.0 mg
    Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
  • Active Comparator: Stage 2: ranibizumab 0.5 mg
    Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
  • Experimental: Stage 3: AGN-150998 2.0 mg
    Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
  • Experimental: Stage 3: AGN-150998 1.0 mg
    Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
  • Active Comparator: Stage 3: ranibizumab 0.5 mg
    Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.

Primary Outcome Measure

Highest Tolerated Dose (HTD) of AGN-150998 [ Time Frame: 24 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--

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By condition
Age-related macular degeneration
By specialty
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