A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients (RIVAL)

Novartis

Status and phase: Completed; Phase 4

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Aflibercept 2.0 mg; Drug: Ranibizumab 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02130024

CRFB002AAU17

Details and patient eligibility

About

The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.

Full description

In each arm, patients underwent three monthly loading doses (at Baseline, Week 4, and Week 8). From Week 8, after the patient had received their third injection of study treatment, the visit intervals were determined by the patient's disease activity. If any of the protocol-specified signs of disease activity were present in the study eye, the subsequent injection visit interval was kept at 4 weeks. If none of the signs were present, the subsequent injection interval was extended by 2-week increments up until a maximum of 12-weekly intervals was reached. If there were any signs of disease activity in the study eye, the treatment interval was reduced as specified in the protocol. The planned individual duration of study participation was 24 months.

Enrollment: 281 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent.

Inclusion criteria specific to the study eye:

• Diagnosis of active subfoveal Choroidal Neovascularisation (CNV) secondary to wet Age-related Macular Degeneration (AMD);
• Best Corrected Visual Acuity (BCVA) score of 23 letters or more as measured by 3-metre Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts.

Exclusion criteria

• Pregnant, nursing, or at risk of becoming pregnant during the study;
• Inability to comply with the study or follow-up procedures;
• Recent (3 months) stroke or myocardial infarction; uncontrolled hypertension; hypersensitivity to the study treatments or to fluorescein;
• In either eye: active periocular or ocular infection or inflammation; iris neovascularisation; uncontrolled or neovascular glaucoma; or one or more patch of geographic atrophy (GA) as specified in the protocol.

Exclusion criteria specific to the study eye:

• Prior or current treatment with anti-angiogenic drugs or corticosteroids;
• Other eye conditions as specified in the protocol;
• Any intraocular procedure carried out within 2 months before baseline or anticipated within 6 months following baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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281 participants in 2 patient groups

Ranibizumab 0.5 mg

Experimental group

Description:

3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]

Treatment:

Drug: Ranibizumab 0.5 mg

Aflibercept 2.0 mg

Active Comparator group

Description:

3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]

Treatment:

Drug: Aflibercept 2.0 mg