PDS Implant with Ranibizumab for Age-Related Macular Degeneration
(Portal Trial)
Recruiting in Palo Alto (17 mi)
+155 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Hoffmann-La Roche
Must be taking: Anti-VEGF injections
Must not be taking: Systemic anti-VEGF, Oral corticosteroids
Disqualifiers: Pregnancy, Ocular diseases, Uncontrolled hypertension, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that participants do not use certain medications, as there is a 'Prohibited Therapy' list. If you are on any continuous medications, you may need to stop them if they are on this list. Please consult with the trial coordinators for specific details.
What data supports the effectiveness of the drug Ranibizumab for age-related macular degeneration?
Research shows that Ranibizumab is effective in treating age-related macular degeneration, with studies indicating positive outcomes over 5 to 7 years of treatment. The Port Delivery System with Ranibizumab (Susvimo) is being developed to address unmet needs in this area, suggesting ongoing improvements in treatment delivery.
12345Is the PDS Implant with Ranibizumab safe for humans?
Ranibizumab, also known as Lucentis or Susvimo, has been studied for safety in treating age-related macular degeneration. Research shows that it is generally safe, with no significant increase in serious side effects compared to those not receiving the treatment.
678910How is the Port Delivery System with ranibizumab different from other treatments for age-related macular degeneration?
The Port Delivery System with ranibizumab is unique because it allows for continuous delivery of the drug, reducing the need for frequent eye injections compared to traditional treatments that require monthly injections.
39111213Eligibility Criteria
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.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)
I can attend all appointments and follow study procedures.
For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
Exclusion Criteria
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
I am not on any medications listed in the 'Prohibited Therapy'.
I don't have eye diseases that would make using ranibizumab risky for me.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the PDS implant and undergo refill-exchanges of ranibizumab 100 mg/mL every 24 weeks
Up to 240 weeks
Visits every 24 weeks, switching to every 12 weeks from Week 144 or 168
Follow-up
Participants are monitored for safety and effectiveness after treatment
72 weeks post-re-implantation
Open-label extension
Participants continue to receive treatment to evaluate long-term safety and tolerability
Long-term
Participant Groups
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.
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.
Ranibizumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Lucentis for:
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic retinopathy (DR)
- Myopic choroidal neovascularization (mCNV)
🇺🇸 Approved in United States as Lucentis/Susvimo for:
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic retinopathy (DR)
- Myopic choroidal neovascularization (mCNV)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Charles Retina InstituteMemphis, TN
Retina Consultants of TexasBellaire, TX
Palmetto Retina CenterFlorence, SC
Eye Center of Northern COFort Collins, CO
More Trial Locations
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Who Is Running the Clinical Trial?
Hoffmann-La RocheLead Sponsor
References
Seven-year outcomes in ranibizumab-treated patients in ANCHOR, MARINA, and HORIZON: a multicenter cohort study (SEVEN-UP). [2022]To assess long-term outcomes 7 to 8 years after initiation of intensive ranibizumab therapy in exudative age-related macular degeneration (AMD) patients.
Five-year Outcomes of Ranibizumab in Neovascular Age-related Macular Degeneration: Real Life Clinical Experience. [2022]To evaluate the outcomes of 5-year ranibizumab treatment in neovascular age-related macular degeneration (nAMD) in a single center and real life clinical setting.
Development of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration. [2023]This review provides background on the remaining unmet needs with antivascular endothelial growth factor (VEGF) therapies for the treatment of neovascular age-related macular degeneration (nAMD). We also discuss the developmental story of the Port Delivery System with ranibizumab (PDS; SUSVIMO, Genentech, Inc., South San Francisco, CA, USA).
ROLE OF ADDITIONAL DEXAMETHASONE FOR THE MANAGEMENT OF PERSISTENT OR RECURRENT NEOVASCULAR AGE-RELATED MACULAR DEGENERATION UNDER RANIBIZUMAB TREATMENT. [2022]To assess the efficacy of a combination therapy of intravitreal ranibizumab together with a dexamethasone implant in comparison with ranibizumab monotherapy in neovascular age-related macular degeneration.
Effectiveness of Continued Ranibizumab Therapy in Neovascular Age-Related Macular Degeneration versus Switch to Aflibercept: Real World Evidence. [2019]To assess the long-term comparative effectiveness of ranibizumab versus switching to aflibercept in neovascular age-related macular degeneration (nAMD).
Safety of ranibizumab therapy in wet AMD and the role of vascular endothelial growth factors in physiological angiogenesis. [2015]Vascular endothelial growth factor - A (VEGF-A), is a major factor implicated in choroidal neovascularisation (CNV) and therefore a target for therapeutic agents in wet age related macular degeneration (AMD). Ranibiuzumab (Lucentis) blocks all active isoforms of VEGF-A and the products of their degradation. It penetrates through all layers of the retina in order to reach the target tissue. It is quickly removed from the system and it is characterised by low level of immunogenicity. The essence of angiogenesis is formation of new vessels by branching and expansion of already existing ones. Angiogenesis is an important physiological process that takes place during the healing of wounds, reconstruction of hypoxic injury and reproduction. However some diseases such as cancer, arthritis, diabetes and neovascular AMD are associated with persistent unregulated angiogenesis. There is an important question whether binding vascular-endothelial growth factors in wet AMD therapies using ranibizumab is correlated with the increase of the incidence of systematic adverse effects (AEs), such as cardiovascular episodes or thrombosis. The aim of this article is to present ranibizumab as a safe drug in treating wet AMD patients. Even though the concentration of Lucentis administered in a dose of 0.3 or 0.5 mg into the vitreous body in the organism is very low, the incidence of AEs during the anti-VEGF therapy was traced. In MARINA and ANCHOR studies, occurrence of possible AEs was observed. No statistically significant differences were shown in the AEs frequency between the patients treated with ranibizumab and the control group, and in correlation with the general population of patients suffering from wet AMD.
The Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration: Results from the Randomized Phase 2 Ladder Clinical Trial. [2020]To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) treatment.
Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. [2021]To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study.
HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. [2022]To evaluate the long-term safety and efficacy of multiple intravitreal ranibizumab injections (Lucentis, Genentech, Inc., South San Francisco, CA) administered at the investigator's discretion in patients with choroidal neovascularization secondary to age-related macular degeneration.
The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration. [2022]To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD).
Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. [2022]The port delivery system (PDS) with ranibizumab has demonstrated noninferior and equivalent efficacy compared with monthly intravitreal injections of ranibizumab, an anti-vascular endothelial growth factor (VEGF) agent, in patients with neovascular age-related macular degeneration (nAMD), but evaluating patient preference is important to help inform clinical decision-making.
Prevalence and Progression of Macular Atrophy in Eyes with Neovascular Age-Related Macular Degeneration in the Phase 2 Ladder Trial of the Port Delivery System with Ranibizumab. [2022]To determine whether the rates of macular atrophy (MA) differ between eyes with neovascular age-related macular degeneration (nAMD) treated continuously with the Port Delivery System with ranibizumab (PDS) and those treated with ranibizumab given as a bolus intravitreal injection.
Visual acuity outcomes in ranibizumab-treated neovascular age-related macular degeneration; stratified by baseline vision. [2016]Ranibizumab (Lucentis, Novartis, Basel, Switzerland) is currently indicated for use in neovascular age-related macular degeneration (NVAMD). This study assessed the real-life outcomes based on baseline visual acuity when treated with intravitreal ranibizumab on a three + pro re nata (PRN) dosing schedule for NVAMD.