Tampa, Florida 33609

  • Macular Degeneration

Purpose:

This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of three different formulations of ranibizumab delivered via RPDS implant compared with the standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with subfoveal neovascular AMD.


Criteria:

Inclusion Criteria: - Newly diagnosed with wet AMD within 9 months of screening visit - Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit - Demonstrated response to prior ITV anti-VEGF treatment - Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent Exclusion Criteria: - Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye - Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit - History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye - Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit - Subretinal hemorrhage in the study eye that involves the center of the fovea - Subfoveal fibrosis, or atrophy in the study eye - Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia - Uncontrolled ocular hypertension or glaucoma in the study eye - History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye - Uncontrolled blood pressure - Uncontrolled atrial fibrillation within 3 months of informed consent - History of myocardial infarction or stroke within the last 3 months prior to informed consent - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications - Use of oral corticosteroids - Current treatment for any active systemic infection - Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects - Active malignancy within 12 months of randomization - History of allergy to fluorescein - Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)


Study is Available At:


Original ID:

GX28228


NCT ID:

NCT02510794


Secondary ID:


Study Acronym:


Brief Title:

Study of the Efficacy and Safety of the Ranibizumab Port Delivery System (RPDS) for Sustained Delivery of Ranibizumab in Participants With Subfoveal N


Official Title:

A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Genentech, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

238


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Start Date:September 28, 2015
Completion Date:March 28, 2019
Completion Type:Actual
Primary Completion Date:April 10, 2018
Primary Completion Type:Actual
Verification Date:June 2019
Last Changed Date:June 6, 2019
First Received Date:July 17, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Percentage of Participants With Positive Serum Antibodies to Ranibizumab
Time Frame:Baseline, Predose (0 hour) on Day 14, Months 1, 3, 6, 9, and at early termination (up to approximate
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame:Baseline up to approximately Month 38
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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 approximately 38 months (detailed timeframe is provided in descripti
Safety Issues:False
Description:ITV: Predose (0 hour) on Day 1 and Months 1,3,6,9, and at study completion (up to approximately 38 months); RPDS: Predose (0 hour) on Day 1, 1 hour post treatment on Day 1, Day 2, Day 7, and Day 14, Predose (0 hour) Monthly and as applicable on Day 1 and
Outcome Type:Secondary Outcome
Measure:Observed Serum Concentration (Ct) of Ranibizumab Over Time
Time Frame:Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in descripti
Safety Issues:False
Description:ITV: Predose (0 hour) on Day 1 and Months 1,3,6,9, and at study completion (up to approximately 38 months); RPDS: Predose (0 hour) on Day 1, 1 hour post treatment on Day 1, Day 2, Day 7, and Day 14, Predose (0 hour) Monthly and as applicable on Day 1 and
Outcome Type:Secondary Outcome
Measure:Terminal Half-Life (t1/2) of Ranibizumab
Time Frame:Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in descripti
Safety Issues:False
Description:ITV: Predose (0 hour) on Day 1 and Months 1,3,6,9, and at study completion (up to approximately 38 months); RPDS: Predose (0 hour) on Day 1, 1 hour post treatment on Day 1, Day 2, Day 7, and Day 14, Predose (0 hour) Monthly and as applicable on Day 1 and
Outcome Type:Secondary Outcome
Measure:Time to Maximum Concentration (Tmax) of Ranibizumab
Time Frame:Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in descripti
Safety Issues:False
Description:ITV: Predose (0 hour) on Day 1 and Months 1,3,6,9, and at study completion (up to approximately 38 months); RPDS: Predose (0 hour) on Day 1, 1 hour post treatment on Day 1, Day 2, Day 7, and Day 14, Predose (0 hour) Monthly and as applicable on Day 1 and
Outcome Type:Secondary Outcome
Measure:Area Under the Concentration-Time Curve (AUC) of Ranibizumab
Time Frame:Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in descripti
Safety Issues:False
Description:ITV: Predose (0 hour) on Day 1 and Months 1,3,6,9, and at study completion (up to approximately 38 months); RPDS: Predose (0 hour) on Day 1, 1 hour post treatment on Day 1, Day 2, Day 7, and Day 14, Predose (0 hour) Monthly and as applicable on Day 1 and
Outcome Type:Secondary Outcome
Measure:Observed Maximum Serum concentration (Cmax) of Ranibizumab
Time Frame:Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in descripti
Safety Issues:False
Description:ITV: Predose (0 hour) on Day 1 and Months 1,3,6,9, and at study completion (up to approximately 38 months); RPDS: Predose (0 hour) on Day 1, 1 hour post treatment on Day 1, Day 2, Day 7, and Day 14, Predose (0 hour) Monthly and as applicable on Day 1 and
Outcome Type:Secondary Outcome
Measure:Number of Implant Clogging at Month 9
Time Frame:Month 9
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Time Frame:Baseline up to Month 38
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Average Change From Baseline in BCVA Over Time
Time Frame:Baseline up to Month 38
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in BCVA Over Time
Time Frame:Baseline up to Month 38
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 9
Time Frame:Baseline, Month 9
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Time Until a Participant First Requires the RPDS Implant Refill According to Protocol-Defined Refill Criteria
Time Frame:Baseline up to approximately 38 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ranibizumab
Description: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 (Dose 1, 2 and 3).
Arm Name:Ranibizumab Dose 1
Other Name:Lucentis®

Study Arms

Study Arm Type:Experimental
Arm Name:Ranibizumab Dose 1
Description:Participants will receive ranibizumab delivered through the implant with Dose 1 formulation in the study eye on Day 1 and if required, implant refill will be done starting from Month 1 according to protocol-defined refill criteria.
Study Arm Type:Experimental
Arm Name:Ranibizumab Dose 2
Description:Participants will receive ranibizumab delivered through the implant with Dose 2 formulation in the study eye on Day 1 and if required, implant refill will be done starting from Month 1 according to protocol-defined refill criteria.
Study Arm Type:Experimental
Arm Name:Ranibizumab Dose 3
Description:Participants will receive ranibizumab delivered through the implant with Dose 3 formulation in the study eye on Day 1 and if required, implant refill will be done starting from Month 1 according to protocol-defined refill criteria.
Study Arm Type:Active Comparator
Arm Name:Ranibizumab 0.5 mg ITV injection
Description:Participants will receive ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Genentech, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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