Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD) (CAPELLA)

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Intravitreal Aflibercept Injection (IAI); Drug: REGN2176-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02418754

R2176-3-AMD-1417

Details and patient eligibility

About

The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.

The secondary objectives of the study were the following:

• To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
• To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
• To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD

Enrollment: 505 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Men or women ≥50 years of age
2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
4. Provide signed informed consent

Key Exclusion Criteria:

1. Any prior treatment with anti-VEGF treatment in the study eye
2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
5. Prior vitrectomy in the study eye
6. Any history of macular hole of stage 2 and above in the study eye
7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
8. History of corneal transplant in the study eye
9. Evidence of diabetic retinopathy or diabetic macular edema in either eye
10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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505 participants in 5 patient groups

REGN2176-3 (1 mg: 2 mg)

Experimental group

Description:

Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.

Treatment:

Drug: REGN2176-3

REGN2176-3 (3 mg: 2 mg)

Experimental group

Description:

Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.

Treatment:

Drug: REGN2176-3

Intravitreal Aflibercept Injection (IAI) 2 mg

Experimental group

Description:

IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)

REGN2176-3 (3 mg: 2 mg) to IAI 2 mg

Experimental group

Description:

Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)

IAI 2 mg to REGN2176-3 (3 mg:2 mg)

Experimental group

Description:

IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.

Treatment:

Drug: REGN2176-3