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Clinical Trials/EUCTR2016-000423-13-HU
EUCTR2016-000423-13-HUActive, not recruitingPhase 1

A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETYAND TOLERABILITY OF LAMPALIZUMAB IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION WHO HAVE COMPLETED AROCHE-SPONSORED STUDY - Omaspect

F. Hoffmann-La Roche Ltd0 sites1,800 target enrollmentStarted: August 18, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
1,800
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of both treatment and the Week 96 visit
  • •- Agreement to remain abstinent or use a reliable form of contraception among all men and women of child-bearing potential
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 90
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 1710

Exclusion Criteria

  • •- Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • •- Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • •- Predisposition to or history of increased risk of infection
  • •- Pregnancy or lactation

Investigators

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