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Monoclonal Antibodies

PDS Implant with Ranibizumab for Age-Related Macular Degeneration (Portal Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability and willingness to undertake all scheduled visits and assessments

Be older than 18 years old

Must not have

Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab

Requirement for continuous use of any medications or treatments indicated in the 'Prohibited Therapy'

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 240

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study the long-term effects of a treatment for neovascular age-related macular degeneration.

Who is the study for?

This trial is for patients with neovascular age-related macular degeneration who completed certain previous studies (Ladder, Archway, or Velodrome) without early discontinuation. Participants must be able to attend all visits and assessments. Women of childbearing potential must agree to use contraception or remain abstinent.

What is being tested?

The study tests the long-term safety of a Port Delivery System with ranibizumab (PDS), which is an implant designed to continuously deliver medication for treating nAMD over an extended period without frequent injections.

What are the potential side effects?

Possible side effects include eye irritation, increased risk of eye infection, bleeding inside the eye, retinal detachment, cataracts and floaters. There may also be general reactions like headache or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can attend all appointments and follow study procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I am not on any medications listed in the 'Prohibited Therapy'.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 240

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 240

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 240 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

11Treatment groups

Experimental Treatment

Group I: Sub-study 2: Cohort 2bExperimental Treatment1 Intervention

Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.

Group II: Sub-study 2: Cohort 2aExperimental Treatment1 Intervention

Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.

Group III: Sub-study 2: Cohort 1Experimental Treatment1 Intervention

Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W

Group IV: Sub-study 1: PDS ImplantExperimental Treatment1 Intervention

Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W.

Group V: PDS Implant Cohort 7 (ex-US only)Experimental Treatment1 Intervention

Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W

Group VI: PDS Implant Cohort 6 (ex-US only)Experimental Treatment1 Intervention

Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W

Group VII: PDS Implant Cohort 5 (ex-US only)Experimental Treatment1 Intervention

Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W

Group VIII: PDS Implant Cohort 4 (US only)Experimental Treatment1 Intervention

Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

Group IX: PDS Implant Cohort 3 (US only)Experimental Treatment1 Intervention

Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

Group X: PDS Implant Cohort 2 (US only)Experimental Treatment1 Intervention

Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

Group XI: PDS Implant Cohort 1 (US only)Experimental Treatment1 Intervention

Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

0 / 3Eligibility criteria met