Extension Study for the Port Delivery System With Ranibizumab (Portal) (Portal)
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ClinicalTrials.gov Identifier: NCT03683251 |
Recruitment Status :
Recruiting
First Posted : September 25, 2018
Last Update Posted : January 14, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neovascular Age-Related Macular Degeneration | Drug: PDS Implant with Ranibizumab 100 mg/mL | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | September 20, 2018 |
Estimated Primary Completion Date : | September 19, 2025 |
Estimated Study Completion Date : | September 19, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: PDS Implant Cohort 1
Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. |
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
Experimental: PDS Implant Cohort 2
Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. |
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
Experimental: PDS Implant Cohort 3
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. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. |
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
Experimental: PDS Implant Cohort 4
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. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. |
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
Experimental: PDS Implant Cohort 5
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
|
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
Experimental: PDS Implant Cohort 6
Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W
|
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
Experimental: PDS Implant Cohort 7
Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W
|
Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm |
- Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) [ Time Frame: Baseline up to Week 144 ]
- Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs) [ Time Frame: Baseline up to Week 144 ]
- 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 [ Time Frame: Baseline up to Week 144 ]
- 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 [ Time Frame: Baseline up to Week 144 ]
ETDRS = Early Treatment Diabetic Retinopathy Study
A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
- Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time [ Time Frame: Baseline up to Week 144 ]
- Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time [ Time Frame: Baseline up to Week 144 ]
- Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time [ Time Frame: Baseline up to Week 144 ]
- Change from Baseline in Center Point Thickness Over Time [ Time Frame: Baseline up to Week 144 ]
- Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, and Fifth Refill-exchange Interval [ Time Frame: Weeks 16 to Week 136 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
Exclusion Criteria:
- 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
- History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
- History of other diseases, 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 that renders the participant at high risk of treatment complications
- Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683251
Contact: Reference Study ID Number: GR40549 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com |

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03683251 |
Other Study ID Numbers: |
GR40549 2020-004427-16 ( EudraCT Number ) |
First Posted: | September 25, 2018 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |