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

NCT01397409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2019-04-16

Study results available
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Summary

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.

Conditions

  • Age-related Macular Degeneration

Interventions

DRUG

AGN-150998

AGN-150998 Intravitreal injection.

DRUG

ranibizumab

Ranibizumab 0.5 mg given by intravitreal injection.

OTHER

Sham Injection

Stage 3: Sham injection at Weeks 12 and 16.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-01
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • United States
  • Australia
  • Austria
  • France
  • Germany
  • Israel
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01397409 on ClinicalTrials.gov