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 :
Completed
First Posted : September 19, 2018
Results First Posted : March 25, 2022
Last Update Posted : October 4, 2022
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Neovascular Age-Related Macular Degeneration |
Interventions |
Drug: PDS Implant filled with 100 mg/mL Ranibizumab Drug: Intravitreal Injections of 10 mg/mL Ranibizumab |
Enrollment | 415 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | PDS Implant Arm | Intravitreal Arm |
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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 | Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
Period Title: Overall Study | ||
Started | 248 | 167 |
Completed | 234 | 154 |
Not Completed | 14 | 13 |
Reason Not Completed | ||
Adverse Event | 1 | 1 |
Death | 8 | 4 |
Lost to Follow-up | 3 | 0 |
Non-Compliance With Study Drug | 1 | 0 |
Physician Decision | 0 | 1 |
Withdrawal by Subject | 1 | 7 |
Baseline Characteristics
Arm/Group Title | PDS Implant Arm | Intravitreal Arm | Total | |
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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 | Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter. | Total of all reporting groups | |
Overall Number of Baseline Participants | 248 | 167 | 415 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 248 participants | 167 participants | 415 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
26 10.5%
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17 10.2%
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43 10.4%
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>=65 years |
222 89.5%
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150 89.8%
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372 89.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 248 participants | 167 participants | 415 participants | |
75.2 (8.11) | 74.8 (7.63) | 75.0 (7.91) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 248 participants | 167 participants | 415 participants | |
Female |
145 58.5%
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100 59.9%
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245 59.0%
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Male |
103 41.5%
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67 40.1%
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170 41.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 248 participants | 167 participants | 415 participants | |
Hispanic or Latino |
7 2.8%
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8 4.8%
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15 3.6%
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Not Hispanic or Latino |
240 96.8%
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159 95.2%
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399 96.1%
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Unknown or Not Reported |
1 0.4%
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0 0.0%
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1 0.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 248 participants | 167 participants | 415 participants | |
American Indian or Alaska Native |
1 0.4%
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2 1.2%
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3 0.7%
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Asian |
1 0.4%
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0 0.0%
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1 0.2%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
3 1.2%
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1 0.6%
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4 1.0%
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White |
240 96.8%
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161 96.4%
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401 96.6%
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More than one race |
1 0.4%
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0 0.0%
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1 0.2%
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Unknown or Not Reported |
2 0.8%
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3 1.8%
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5 1.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800 821-8590 |
EMail: | global-roche-genentech-trials@gene.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03677934 |
Other Study ID Numbers: |
GR40548 |
First Submitted: | September 11, 2018 |
First Posted: | September 19, 2018 |
Results First Submitted: | November 18, 2021 |
Results First Posted: | March 25, 2022 |
Last Update Posted: | October 4, 2022 |