Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

Phase 3CompletedNCT01948830

Novartis Pharmaceuticals650 enrolled

Overview

This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens. There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

650

Conditions

Interventions

Ranibizumab 0.5mgDRUG

0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Ranibizumab 0.5mgDRUG

0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Male or female patients, ≥50 years of age with signed informed consent before study procedures * Visual impairment predominantly due to nAMD. * Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography * Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT * BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320) Key Exclusion Criteria: * Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. * Stroke or myocardial infarction within 3 months prior to Screening. * Any active periocular or ocular infection or inflammation in both eyes. * Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity. * Presence of amblyopia or amaurosis in the fellow eye. * History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab \[Avastin®\], aflibercept \[Eylea®\]) or vPDT in the study eye. * History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening. * Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Locations (91)

Outcomes

Primary Outcomes

Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement

Time frame: Baseline to month 12

Secondary Outcomes

Number of Visits Scheduled

The number of visits scheduled according to the treat and extend regimen after treatment initiation

Time frame: From Month1 to Month 11

Change in BCVA From Baseline to Month 12

Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters

Time frame: Baseline to Month 12

Average BCVA Change From Baseline to Month 12

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12

Time frame: Baseline and every month for 12 months

Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline

Time frame: Baseline and every month for 12 months

Data from ClinicalTrials.gov

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Novartis Investigative Site

Antwerp, Belgium

Novartis Investigative Site

Ottignies, Belgium

Novartis Investigative Site

Zottegem, Belgium

Novartis Investigative Site

Santiago, Chile

Novartis Investigative Site

Zagreb, Croatia, Croatia

Novartis Investigative Site

Glostrup Municipality, Denmark

Novartis Investigative Site

Roskilde, Denmark

Novartis Investigative Site

Cairo, Abbassia, Egypt

Novartis Investigative Site

Cairo, Egypt

Novartis Investigative Site

Leipzig, Germany, Germany

...and 81 more locations