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

NCT02130024 | Completed Phase 4 Results

• 1 other identifier: CRFB002AAU17
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 22

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.

Conditions

Age-Related Macular Degeneration

Keywords

Age-related macular degeneration; AMD; wet AMD; ranibizumab; aflibercept; geographic atrophy; inject and extend

Outcome Measures

Primary Outcomes (1)

• Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24

  Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.

  Baseline, Month 24

Secondary Outcomes (13)

• Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12

  Baseline, Month 12

• Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study

  Baseline, Month 12, Month 24

• Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24

  Baseline, Month 12, Month 24

• Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24

  Baseline, Month 12, Month 24

• Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24

  Baseline, Month 12, Month 24

Study Arms (2)

Ranibizumab 0.5 mg

EXPERIMENTAL

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

Drug: Ranibizumab 0.5 mg

Aflibercept 2.0 mg

ACTIVE COMPARATOR

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

Drug: Aflibercept 2.0 mg

Interventions

Ranibizumab 0.5 mg DRUG

Administered as an intravitreal injection

Also known as: Lucentis

Ranibizumab 0.5 mg

Aflibercept 2.0 mg DRUG

Administered as an intravitreal injection

Also known as: Eylea

Aflibercept 2.0 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (22)

Novartis Investigative Site

Albury, New South Wales, 2640, Australia

Location

Novartis Investigative Site

Brookvale, New South Wales, 2100, Australia

Location

Novartis Investigative Site

Chatswood, New South Wales, 2067, Australia

Location

Novartis Investigative Site

Hurtsville, New South Wales, 2220, Australia

Location

Novartis Investigative Site

Mona Vale, New South Wales, Australia

Location

Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

Location

Novartis Investigative Site

Strathfield, New South Wales, 2035, Australia

Location

Novartis Investigative Site

Strathfield, New South Wales, 2135, Australia

Location

Novartis Investigative Site

Sydney, New South Wales, 2000, Australia

Location

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

Sydney, NSW 2000, AUSTRALIA, Australia

Location

Novartis Investigative Site

Caboolture, Queensland, 4510, Australia

Location

Novartis Investigative Site

Redcliffe, Queensland, 4020, Australia

Location

Novartis Investigative Site

South Brisbane, Queensland, 4101, Australia

Location

Novartis Investigative Site

Southport, Queensland, 4215, Australia

Location

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

Location

Novartis Investigative Site

South Launceston, Tasmania, 7249, Australia

Location

Novartis Investigative Site

Clayton, Victoria, 3168, Australia

Location

Novartis Investigative Site

Malvern, Victoria, 3144, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3065, Australia

Location

Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

Location

Novartis Investigative Site

Subiaco, Western Australia, 6008, Australia

Location

Related Publications (2)

• 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.

  PMID: 32374423 DERIVED

• 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.

  PMID: 30676617 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Interventions

Ranibizumab; aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Investigators were not masked. The patients, the BCVA assessors, and the Central Reading Center (who set the treatment intervals) were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: May 2, 2014
• Study Start: April 11, 2014
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (22)