NCT03683251|RecruitingPhase 3FDA Drug

Extension Study for the Port Delivery System With Ranibizumab (Portal)

Portal

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

Hoffmann-La Roche ClinicalTrials.gov

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3 other identifiers

GR405492020-004427-162023-507131-38-00

Study Type

interventional

Target

1,000

Locations

14 countries

Sites

163

Timeline

RegisteredSep 2018

StartedSep 2018

CompletionOct 2029

Brief Summary

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,000

participants targeted

Target at P75+ for phase_3

Timeline

42mo left

Started Sep 2018

Longer than P75 for phase_3

Geographic Reach

14 countries

163 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.1 years study duration

Study Progress69%

Sep 2018Oct 2029

First Submitted

Initial submission to the registry

September 18, 2018

Completed

2 days until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed

11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

11.1 years

First QC Date

September 18, 2018

Last Update Submit

April 24, 2026

Conditions

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (17)

Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Baseline up to Week 240
Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)
Baseline up to Week 240
Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study
Baseline up to Week 240
Incidence and Severity of Adverse Device Effects
Baseline up to Week 240
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects
Baseline up to Week 240
Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit After Implant Insertion Surgery.
Baseline to Week 4
Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs
Baseline to Week 72
Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs
Baseline to Week 72
Sub-study 2: Duration of AESIs
Baseline to Week 72
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period
Up to Day 37 post re-implantation
Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period
> 37 days post re-implantation (up to approximately Week 72)
Sub-study 2: Duration of Ocular AESIs During the Post-operative Period
Up to Day 37 post re-implantation
Sub-study 2: Duration of Ocular AESIs During the Follow-up Period
> 37 days post re-implantation (up to approximately Week 72)
Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs
Baseline to Week 72
Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs
Baseline to Week 72
Sub-study 2: Duration of Anticipated Serious ADEs
Baseline to Week 72
Sub-study 2: Number of Device Deficiencies
Baseline to Week 72

Secondary Outcomes (21)

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
Baseline up to Week 240
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
Baseline up to Week 240
Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time
Baseline up to Week 240
Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time
Baseline up to Week 240
Change from Baseline in Center Point Thickness (CPT) Over Time
Baseline up to Week 240
+16 more secondary outcomes

Study Arms (11)

PDS Implant Cohort 1 (US only)

EXPERIMENTAL

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.