Phase 4 N=281 Randomized Single-blind Treatment

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

Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02130024 ↗

Enrolled (actual)

281

Serious AEs

38.6%

Results posted

Jun 2019

Primary outcome: Primary: Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24 — 0.024; 0.050; 0.363; 0.285 mm — p=0.236

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ranibizumab 0.5 mg (Drug); Aflibercept 2.0 mg (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24	0.024; 0.050; 0.363; 0.285	0.236
SECONDARY Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12	0.024; 0.050; 0.155; 0.145	0.769
SECONDARY Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study	17.6; 20.3; 15.1; 7.2; 28.8; 25.4	0.586
SECONDARY Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24	9.7; 9.7; 8.9; 8.3; 17.7; 17.0	0.733
SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24	65.3; 65.1; 6.9; 5.2; 6.5; 5.3	0.079
SECONDARY Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24	468.2; 483.5; -147.2; -171.6; -151.3; -181.7	0.294
SECONDARY Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)	56.9; 61.3; 55.9; 63.6; 57.3; 60.6	0.461
SECONDARY Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24	22.0; 20.7; 24.8; 18.5	0.891
SECONDARY Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24	96.9; 95.0; 94.0; 94.4	0.460
SECONDARY Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months	2.3; 2.3	—
SECONDARY Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment	44.29; 41.88; -0.48; -26.37; 0.48; -25.14	<0.001 sig
SECONDARY Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24	2.5; 2.7; 96.7; 97.3; 0.8; 0	—
SECONDARY Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells	99.3; 98.5; 0.7; 1.5; 0; 0	—
SECONDARY Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare	97.8; 99.3; 2.2; 0.7; 0; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02130024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.