Safety and Efficacy of Switching From Aflibercept to Ranibizumab in Patients With nAMD

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02161575
Phase
PHASE4
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intraveal injections of 0.5mg ranibizumab

Study Details

AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and blindness registration in the UK . It is a disease which affects the retina (the nerve and blood vessel network at the back of the eye responsible for vision). Patients can suffer with severe visual loss and have difficulties with every day tasks such as recognising faces, reading \& driving. There are two variations of the disease, a 'dry' type \& a 'wet' type also known as neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the retina, in part due to higher than normal levels of a protein called Vascular Endothelial Growth Factor (VEGF). Since the introduction of drugs which block VEGF, visual outcomes for patients with wAMD have dramatically improved. There are 2 widely used treatments; ranibizumab and aflibercept. Whilst the majority of patients have a successful outcome with treatment, many patients experience suboptimal response. This study evaluated if these patients experience a benefit from a switch to a different antiVEGF drug treatment. In this study nAMD patients who are showing no or poor to response to treatment with aflibercept were switched to ranibizumab to assess if there is any benefit in terms of treatment outcomes. Patients visited the hospital clinic 8 times over the 7 - 8 month study period. Monthly ranibizumab injections were given for the first 3 months, then monthly as required for the next 3 months.

Key Dates

First listed
Jun 11, 2014
Start date
Aug 28, 2014
Status verified
Feb 2019
Primary completion
Sep 14, 2017
Completion
Sep 14, 2017

Study Design

Enrollment
103 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.

Primary Outcome Measure

Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90. [ Time Frame: Baseline and Day 90 ]

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