Phase 3
Completed N=415
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
Source: ClinicalTrials.gov NCT03677934 ↗Enrolled (actual)
415
Serious AEs
28.2%
Results posted
Mar 2022
Primary outcomePrimary: 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 — 0.2; 0.5 letters
◆ Published Evidence
Established
23citations · ~6 / year
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.
Summary
Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).
Linked Publications (5)
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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.
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Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration.
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Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development.
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Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections.
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Supplemental Intravitreal Ranibizumab Injections in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.2; 0.5 | — |
| SECONDARY Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64 |
-0.4; -0.8 | — |
| SECONDARY Change From Baseline in BCVA Score Over Time |
-4.3; -0.4; -1.7; 0.1; -0.4; 0.6 | — |
| SECONDARY 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 |
1.2; 1.8 | — |
| SECONDARY Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time |
2.7; 5.3 | — |
| SECONDARY 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 |
80.7; 82.1 | — |
| SECONDARY Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time |
75.6; 78.1 | — |
| SECONDARY Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40 |
95.1; 95.1; 85.0; 88.3 | — |
| SECONDARY Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time |
88.9; 84.1; 75.1; 73.5 | — |
| SECONDARY Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40 |
57.8; 58.9 | — |
| SECONDARY Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time |
52.4; 55.6 | — |
| SECONDARY Change From Baseline in Center Point Thickness (CPT) at Week 36 |
176.9; 177.4; 5.4; 2.6 | — |
| SECONDARY Change From Baseline in CPT Over Time |
176.9; 177.4; 0.2; 2.1; 0.3; 3.0 | — |
| SECONDARY 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 |
4; 242; 13; 228; 12; 219 | — |
| SECONDARY Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additional Supplemental Treatments During the Study |
4.1; 0.8; 0.4 | — |
| SECONDARY Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs |
242; 87; 124; 65; 213; 121 | — |
| SECONDARY Percentage of Participants With Adverse Events of Special Interest |
64; 18; 21; 6; 0; 0 | — |
| SECONDARY Observed Serum Ranibizumab Concentrations at Specified Timepoints |
0.125; 0.117; 0.397; 0.0592; 0.564; 0.0581 | — |
| SECONDARY Estimated PK Parameter Values AUC0-6M |
59.42 | — |
| SECONDARY Estimated PK Parameter Value t1/2 After PDS Implant Insertion |
442.29 | — |
| SECONDARY Estimated PK Parameter Value Cmin |
0.31 | — |
| SECONDARY Estimated PK Parameter Value Cmax |
0.47 | — |
| SECONDARY Baseline Prevalence and Incidence of Treatment-Emergent ADA |
5; 8; 238; 154; 38; 21 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03677934) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.