A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway)

Roche

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Intravitreal Injections of 10 mg/mL Ranibizumab; Drug: PDS Implant filled with 100 mg/mL Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03677934

GR40548

Details and patient eligibility

About

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

Enrollment: 415 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥50 years, at time of signing Informed Consent Form
• Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
• Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
• Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
• Best-corrected visual acuity (BCVA) of 34 letters or better

Exclusion criteria

• Subfoveal fibrosis or subfoveal atrophy in study eye
• Subretinal hemorrhage that involves the center of the fovea in study eye
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
• Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
• Previous intraocular device implantation in study eye
• Previous laser (any type) used for AMD treatment in study eye
• Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
• Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
• CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
• Uncontrolled blood pressure
• History of stroke within the last 3 months prior to informed consent
• Uncontrolled atrial fibrillation within 3 months of informed consent
• History of myocardial infarction within the last 3 months prior to informed consent
• History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator
• Current systemic treatment for a confirmed active systemic infection
• Chronic use of oral corticosteroids
• Active cancer within 12 months of randomization
• Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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415 participants in 2 patient groups

PDS Implant Arm

Experimental group

Description:

Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals

Treatment:

Drug: PDS Implant filled with 100 mg/mL Ranibizumab

Intravitreal Arm

Active Comparator group

Description:

Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.

Treatment:

Drug: Intravitreal Injections of 10 mg/mL Ranibizumab