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

NCT ID: NCT02130024

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-11
• Study Completion Date: 2017-11-15

Brief Summary

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.

Detailed 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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ranibizumab 0.5 mg

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

Group Type: EXPERIMENTAL

Ranibizumab 0.5 mg

Intervention Type: DRUG

Administered as an intravitreal injection

Aflibercept 2.0 mg

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

Group Type: ACTIVE_COMPARATOR

Aflibercept 2.0 mg

Intervention Type: DRUG

Administered as an intravitreal injection

Interventions

Ranibizumab 0.5 mg

Administered as an intravitreal injection

Intervention Type: DRUG

Aflibercept 2.0 mg

Administered as an intravitreal injection

Intervention Type: DRUG

Other Intervention Names

Lucentis; Eylea

Eligibility Criteria

Inclusion Criteria

• Written informed consent.

• 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.

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Albury, New South Wales, Australia

Novartis Investigative Site

Brookvale, New South Wales, Australia

Novartis Investigative Site

Chatswood, New South Wales, Australia

Novartis Investigative Site

Hurtsville, New South Wales, Australia

Novartis Investigative Site

Mona Vale, New South Wales, Australia

Novartis Investigative Site

Parramatta, New South Wales, Australia

Novartis Investigative Site

Strathfield, New South Wales, Australia

Novartis Investigative Site

Strathfield, New South Wales, Australia

Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Sydney, NSW 2000, Australia

Novartis Investigative Site

Caboolture, Queensland, Australia

Novartis Investigative Site

Redcliffe, Queensland, Australia

Novartis Investigative Site

South Brisbane, Queensland, Australia

Novartis Investigative Site

Southport, Queensland, Australia

Novartis Investigative Site

Adelaide, South Australia, Australia

Novartis Investigative Site

South Launceston, Tasmania, Australia

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Malvern, Victoria, Australia

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Nedlands, Western Australia, Australia

Novartis Investigative Site

Subiaco, Western Australia, Australia

Countries

Australia

References

Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.

Reference Type: DERIVED

PMID: 32374423 (View on PubMed)

Gillies MC, Hunyor AP, Arnold JJ, Guymer RH, Wolf S, Ng P, Pecheur FL, McAllister IL. Effect of Ranibizumab and Aflibercept on Best-Corrected Visual Acuity in Treat-and-Extend for Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):372-379. doi: 10.1001/jamaophthalmol.2018.6776.

Reference Type: DERIVED

PMID: 30676617 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CRFB002AAU17

Identifier Type: -

Identifier Source: org_study_id