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)
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ClinicalTrials.gov Identifier: NCT03677934 |
Recruitment Status :
Active, not recruiting
First Posted : September 19, 2018
Last Update Posted : July 15, 2020
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Condition or disease | Intervention/treatment | Phase |
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Neovascular Age-Related Macular Degeneration | Drug: PDS Implant filled with 100 mg/mL Ranibizumab Drug: Intravitreal Injections of 10 mg/mL Ranibizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 418 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration |
Actual Study Start Date : | September 12, 2018 |
Actual Primary Completion Date : | March 27, 2020 |
Estimated Study Completion Date : | April 26, 2021 |

Arm | Intervention/treatment |
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Experimental: PDS Implant Arm
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
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Drug: PDS Implant filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm. |
Active Comparator: Intravitreal Arm
Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
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Drug: Intravitreal Injections of 10 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm. |
- Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters [ Time Frame: Baseline to Week 40 ]
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.
- Change from Baseline in BCVA Score Averaged Over Week 60 and Week 64 [ Time Frame: Baseline to Week 64 ]
- Change From Baseline in BCVA Score Over Time [ Time Frame: Baseline up to Week 96 ]
- Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40 [ Time Frame: Baseline to Week 40 ]
- Percentage of participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time [ Time Frame: Baseline up to Week 96 ]
- Percentage of participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Average Over Week 36 and Week 40 [ Time Frame: Baseline to Week 40 ]
- Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time [ Time Frame: Baseline up to Week 96 ]
- Percentage of Participants who Lose <10 or <5 Letters in BCVA score from Baseline to the Average Over Week 36 and Week 40 [ Time Frame: Baseline to Week 40 ]
- Percentage of Participants who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time [ Time Frame: Baseline up to Week 96 ]
- Percentage of Participants who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40 [ Time Frame: Baseline up to Week 40 ]
- Percentage of Participants who Gain ≥0 Letters in BCVA Score From Baseline Over Time [ Time Frame: Baseline up to Week 96 ]
- Change From Baseline in Center Point Thickness (CPT) at Week 36 [ Time Frame: Baseline to Week 36 ]
- Change From Baseline in CPT Over Time [ Time Frame: Baseline up to Week 96 ]
- Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, and Fourth Fixed Refill-Exchange Intervals [ Time Frame: Week 16 to Week 92 ]
- Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additional Supplemental Treatments During the Study [ Time Frame: Week 16 to Week 92 ]
- Incidence and Severity of Ocular and Systemic (Non-Ocular) AEs [ Time Frame: Randomization to Week 96 ]AEs = Adverse Events
- Incidence, Severity, and Duration of AESIs [ Time Frame: Randomization to Week 96 ]AESIs = Adverse Events of Special Interest
- Incidence, Severity, and Duration of PDS-Associated AESIs During the Postoperative Period (up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) [ Time Frame: Randomization to Week 96 ]
- Observed Serum Ranibizumab Concentrations at Specified Timepoints [ Time Frame: Randomization to Week 96 ]
- Estimated PK Parameter Values AUC0-6M [ Time Frame: Randomization to Week 96 ]AUC0-6M = Area Under the Concentration-Time Curve From 0 to 6 Months
- Estimated PK Parameter Value t1/2 After PDS Implant Insertion [ Time Frame: Randomization to Week 96 ]t1/2 = Half-Life
- Estimated PK Parameter Value Cmin [ Time Frame: Randomization to Week 96 ]Cmin = Minimum Serum Concentration
- Estimated PK Parameter Value Cmax [ Time Frame: Randomization to Week 96 ]Cmax = Maximum Serum Concentration
- Participants who Were ADA Negative at Baseline and Became Positive Only After Dosing [ Time Frame: Randomization to Week 96 ]ADA = Anti-Drug Antibody
- Participants who Were ADA Positive at Randomization and ADA Titer Increased After Dosing [ Time Frame: Randomization to Week 96 ]
- Participants who Were ADA Positive at Randomization and ADA Titer did not Increase After Dosing [ Time Frame: Randomization to Week 96 ]

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:
- 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)

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): NCT03677934

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03677934 |
Other Study ID Numbers: |
GR40548 |
First Posted: | September 19, 2018 Key Record Dates |
Last Update Posted: | July 15, 2020 |
Last Verified: | July 2020 |
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.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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 |