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Clinical trial

Study of the Efficacy and Safety of the Ranibizumab Port Delivery System (RPDS) for Sustained Delivery of Ranibizumab in Participants With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) (LADDER)

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Last updated:28th Sep 2015
Identifier: NCT02510794

Brief Summary:
This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of three different formulations of ranibizumab delivered via RPDS implant compared with the standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with subfoveal neovascular AMD.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Actual Study Start Date: September 28, 2015
Actual Primary Completion Date: May 30, 2018
Estimated Study Completion Date: February 2, 2019

Arm:
- Experimental:
Ranibizumab Dose 1
- Experimental: Ranibizumab Dose 2
- Experimental: Ranibizumab Dose 3
- Active Comparator: Ranibizumab 0.5 mg ITV injection

Category Value
Date last updated at source 2018-08-08
Study type(s) Interventional
Expected enrolment 220
Study start date 2015-09-28
Estimated primary completion date 2018-05-30

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