A Phase 2 interventional study of Ranibizumab in Macular Degeneration, sponsored by Genentech, Inc.. Completed at 50 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal neovascular age-related macular degeneration (nAMD).
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 225 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Drug: Ranibizumab
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Drug: Ranibizumab
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Drug: Ranibizumab
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Drug: Ranibizumab
Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations.
Also known as: Lucentis®
Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria
Protocol-Defined Refill Criteria At 1 month after initial fill: * Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: * Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR * Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR * Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity
Time frame: Baseline up to approximately 38 months
Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Time frame: Baseline, Months 9, 10
Change From Baseline in BCVA Over Time
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Time frame: Baseline up to Month 10
Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis)
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).
Time frame: Baseline up to Month 10
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea
Time frame: Baseline up to Month 9
Number of Implant Clogging at Month 9
Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.
Time frame: Month 9
Observed Maximum Serum Concentration (Cmax) of Ranibizumab
The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time frame: Predose (0 hour) on Day 1 up to 38 months
Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab
AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time frame: Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field)
Time to Maximum Concentration (Tmax) of Ranibizumab
The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time frame: Predose (0 hour) on Day 1 up to 38 months
Terminal Half-Life (t1/2) of Ranibizumab
The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Time frame: Predose (0 hour) on Day 1 up to 38 months
Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab
Time frame: Predose (0 hour) on Day 1 up to 38 months
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Baseline up to approximately Month 38
Percentage of Participants With Positive Serum Antibodies to Ranibizumab
Time frame: Baseline up to 38 months
Participants with subfoveal neovascularization secondary to AMD diagnosed within 9 months and treated with ITV anti-VEGF agents were enrolled in the study. Written informed consent was obtained before initiation of any study-related procedures. A participant's screening occurred no sooner than 7 days following administration of the last ITV ranibizumab treatment to the study eye. The screening visit was followed by the randomization visit.
| Milestone | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Started | 59 | 62 | 63 | 41 |
| Completed | 51 | 56 | 56 | 36 |
| Not completed | 8 | 6 | 7 | 5 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Death | 1 | 2 | 1 | 1 |
| Withdrew: Lack of efficacy | 3 | 1 | 1 | 0 |
| Withdrew: Participant moved out of the area | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 3 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 4 | 3 |
Protocol-Defined Refill Criteria At 1 month after initial fill: * Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: * Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR * Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR * Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity
| Months | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL |
|---|---|---|---|
| Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria | 8.7 (6.93 to 9.00) | 13.0 (11.76 to 24.61) | 15.8 (12.06 to 20.63) |
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
| Units on scale | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10 | -3.3 (-5.6 to -1.0) | -0.3 (-2.5 to 1.8) | 5.0 (2.8 to 7.2) | 3.2 (0.6 to 5.8) |
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
| Units on scale | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Month 1 | -6.6 (-11.0 to -2.3) | -4.7 (-8.8 to -0.6) | -4.9 (-9.1 to -0.6) | 2.4 (-2.6 to 7.5) |
| Month 2 | -2.4 (-4.3 to -0.6) | -1.4 (-3.2 to 0.4) | 1.6 (-0.2 to 3.5) | 2.0 (-0.2 to 4.2) |
| Month 3 | -0.7 (-2.4 to 1.0) | -0.6 (-2.2 to 1.0) | 2.4 (0.8 to 4.1) | 2.7 (0.7 to 4.7) |
| Month 4 | -1.4 (-3.4 to 0.7) | -1.1 (-3.0 to 0.8) | 3.1 (1.1 to 5.1) | 1.9 (-0.4 to 4.3) |
| Month 5 | -1.3 (-3.4 to 0.8) | -0.6 (-2.5 to 1.4) | 3.8 (1.8 to 5.8) | 3.0 (0.6 to 5.3) |
| Month 6 | -0.4 (-3.0 to 2.3) | -1.7 (-4.3 to 0.8) | 3.8 (1.2 to 6.4) | 2.7 (-0.4 to 5.7) |
| Month 7 | -0.9 (-3.2 to 1.4) | -1.8 (-4.0 to 0.3) | 3.9 (1.7 to 6.1) | 3.5 (0.9 to 6.1) |
| Month 8 | -2.4 (-4.7 to -0.1) | -1.2 (-3.3 to 1.0) | 4.0 (1.8 to 6.2) | 3.3 (0.7 to 5.9) |
| Month 9 | -3.3 (-5.7 to -0.9) | -0.5 (-2.7 to 1.7) | 5.0 (2.7 to 7.3) | 3.9 (1.1 to 6.6) |
| Month 10 | -3.3 (-5.7 to -1.0) | -0.2 (-2.4 to 2.0) | 5.1 (2.8 to 7.3) | 2.5 (-0.2 to 5.2) |
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).
| Units on scale | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis) | -7.5 ± 74.0 | -8.5 ± 59.1 | 29.7 ± 54.7 | 21.3 ± 65.1 |
Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea
| microns | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Month 1 | 16.5 (4.1 to 29.0) | 7.2 (-4.5 to 18.9) | -2.9 (-15.1 to 9.2) | 2.5 (-11.7 to 16.7) |
| Month 2 | 19.8 (6.9 to 32.7) | 11.9 (-0.3 to 24.1) | -1.8 (-14.5 to 10.9) | 1.5 (-13.3 to 16.4) |
| Month 3 | 24.9 (11.5 to 38.3) | 7.3 (-5.5 to 20.0) | 6.4 (-6.8 to 19.6) | -7.3 (-22.9 to 8.3) |
| Month 4 | 31.0 (15.8 to 46.1) | 4.1 (-10.3 to 18.5) | 1.9 (-13.2 to 16.9) | -1.7 (-19.2 to 15.9) |
| Month 5 | 30.9 (16.1 to 45.7) | 0.4 (-13.6 to 14.5) | 8.0 (-6.7 to 22.9) | 4.0 (-13.0 to 21.1) |
| Month 6 | 31.9 (15.6 to 48.1) | 2.1 (-13.1 to 17.3) | 5.9 (-10.0 to 21.7) | -2.0 (-20.4 to 16.4) |
| Month 7 | 39.9 (25.6 to 54.3) | 0.7 (-12.5 to 14.0) | -4.3 (-18.3 to 9.6) | -9.8 (-25.9 to 6.3) |
| Month 8 | 42.8 (26.4 to 59.1) | 3.1 (-12.1 to 18.3) | 5.1 (-10.6 to 20.8) | -2.4 (-20.8 to 16.1) |
| Month 9 | 54.8 (37.1 to 72.4) | -0.7 (-16.9 to 15.5) | -1.7 (-18.5 to 15.1) | -6.3 (-26.1 to 13.4) |
Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.
| Participants | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL |
|---|---|---|---|
| Number of Implant Clogging at Month 9 | 0 | 0 | 0 |
The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
| pg/mL | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Interval following implant insertion before first refill | 105.52 ± 258.0 | 220.87 ± 46.4 | 1080.69 ± 272.5 | — |
| All Dose Intervals | 91.47 ± 187.2 | 297.61 ± 115.2 | 1131.01 ± 256.6 | — |
AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
| ng∙day/mL | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Interval following implant insertion before first refill | 5.89 ± 225.1 | 28.39 ± 107.6 | 90.83 ± 64.7 | — |
| All Dose Intervals | 3.43 ± 176.8 | 22.93 ± 96.9 | 66.12 ± 71.4 | — |
The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
| days | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Interval following implant insertion before first refill | 11.45 (0 to 688.1) | 12.87 (0 to 86.0) | 29.01 (0.8 to 180.3) | — |
| All Dose Intervals | 4.87 (0 to 688.1) | 6.71 (0 to 91.1) | 6.97 (0.8 to 180.3) | — |
The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
| days | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Interval following implant insertion before first refill | 168.20 ± 163.3 | 88.30 ± 46.7 | 119.07 ± 128.4 | — |
| All Dose Intervals | 162.36 ± 129.3 | 118.87 ± 76.2 | 143.87 ± 171.4 | — |
| pg/mL | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| Interval following implant insertion before first refill | 14.96 ± 76.4 | 61.64 ± 95.8 | 129.63 ± 149.2 | — |
| All Dose Intervals | 11.58 ± 65.7 | 105.07 ± 77.4 | 62.19 ± 345.2 | — |
| Participants | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Ranibizumab PD All Participants | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|---|
| Participants with ocular SAEs in study eye | 7 | 6 | 4 | 17 | 0 |
| Participants with ocular AEs in study eye | 56 | 58 | 52 | 166 | 26 |
| Participants with non-ocular SAEs | 8 | 16 | 13 | 37 | 4 |
| Participants with non-ocular AEs | 46 | 52 | 52 | 150 | 36 |
| Percentage of Participants | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Ranibizumab PD All Participants | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|---|
| Participants with a positive sample at time of entry into the study (Baseline) | 10.3 | 5.0 | 5.1 | 6.8 | 0 |
| Participants positive for Treatment Emergent ADA (Post-baseline) | 6.9 | 14.5 | 15.3 | 12.3 | 14.6 |
Collected over Baseline up to approximately Month 38. Non-serious events are listed at a 0.05% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Port Delivery System With Ranibizumab 10mg/mL | 1/58 (1.7%) | 14/58 (24.1%) | 57/58 (98.3%) |
| Port Delivery System With Ranibizumab 40mg/mL | 2/62 (3.2%) | 19/62 (30.6%) | 59/62 (95.2%) |
| Port Delivery System With Ranibizumab 100mg/mL | 1/59 (1.7%) | 17/59 (28.8%) | 58/59 (98.3%) |
| Intravitreal Injection With Ranibizumab 0.5mg | 1/41 (2.4%) | 4/41 (9.8%) | 35/41 (85.4%) |
| Event | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| PNEUMONIAInfections and infestations | 2/58 | 4/62 | 0/59 | 1/41 |
| VITREOUS HAEMORRHAGEEye disorders | 3/58 | 2/62 | 2/59 | 0/41 |
| SEPSISInfections and infestations | 0/58 | 3/62 | 0/59 | 0/41 |
| RHEGMATOGENOUS RETINAL DETACHMENTEye disorders | 2/58 | 1/62 | 2/59 | 0/41 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASERespiratory, thoracic and mediastinal disorders | 2/58 | 0/62 | 0/59 | 0/41 |
| BRONCHITISInfections and infestations | 0/58 | 0/62 | 2/59 | 0/41 |
| ATRIAL FIBRILLATIONCardiac disorders | 0/58 | 2/62 | 0/59 | 0/41 |
| HIATUS HERNIAGastrointestinal disorders | 0/58 | 2/62 | 0/59 | 0/41 |
| INFLUENZAInfections and infestations | 0/58 | 2/62 | 0/59 | 0/41 |
| CEREBROVASCULAR ACCIDENTNervous system disorders | 0/58 | 2/62 | 1/59 | 0/41 |
| Event | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg |
|---|---|---|---|---|
| CONJUNCTIVAL HAEMORRHAGEEye disorders | 41/58 | 44/62 | 37/59 | 8/41 |
| CONJUNCTIVAL HYPERAEMIAEye disorders | 18/58 | 13/62 | 14/59 | 0/41 |
| EYE PAINEye disorders | 12/58 | 12/62 | 15/59 | 5/41 |
| VITREOUS FLOATERSEye disorders | 13/58 | 9/62 | 12/59 | 4/41 |
| IRITISEye disorders | 8/58 | 13/62 | 7/59 | 0/41 |
| NASOPHARYNGITISInfections and infestations | 12/58 | 8/62 | 9/59 | 6/41 |
| CATARACTEye disorders | 3/58 | 5/62 | 12/59 | 5/41 |
| HEADACHENervous system disorders | 9/58 | 8/62 | 11/59 | 1/41 |
| VITREOUS DETACHMENTEye disorders | 7/58 | 6/62 | 4/59 | 7/41 |
| SINUSITISInfections and infestations | 2/58 | 5/62 | 9/59 | 7/41 |
| Age, Categorical(Participants) | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 7 | 9 | 7 | 31 |
| >=65 years | 51 | 55 | 54 | 34 | 194 |
| Age, Continuous(Years) | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg | Total |
|---|---|---|---|---|---|
| Mean | 74.6 ± 8.4 | 75.0 ± 8.5 | 73.8 ± 8.1 | 71.9 ± 8.8 | 74.0 ± 8.4 |
| Sex: Female, Male(Participants) | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg | Total |
|---|---|---|---|---|---|
| Female | 37 | 39 | 42 | 28 | 146 |
| Male | 22 | 23 | 21 | 13 | 79 |
| Ethnicity (NIH/OMB)(Participants) | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 3 | 1 | 10 |
| Not Hispanic or Latino | 56 | 56 | 60 | 39 | 211 |
| Unknown or Not Reported | 0 | 3 | 0 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Port Delivery System With Ranibizumab 10mg/mL | Port Delivery System With Ranibizumab 40mg/mL | Port Delivery System With Ranibizumab 100mg/mL | Intravitreal Injection With Ranibizumab 0.5mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 1 |
| White | 58 | 61 | 60 | 41 | 220 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
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Genentech, Inc.