Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 05 September 2018

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...

purpose

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 08-Aug-18
Study type(s) Interventional
Expected enrolment 220
Study start date 28-Sep-15
Estimated primary completion date 30-May-18

View full details

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Transplantation

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Psoriasis

Psoriasis

See information on psoriasis pathophysiology, signs and symptoms, comorbidities, treatment options, and more.

+ 2 more

Load more

Related Content