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Report for Clinical Trial NCT03683251

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refills administered every 24 weeks (Q24W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder) or Phase III Study GR40548 (Archway).

NCT03683251 Neovascular Age-Related Macular Degeneration
MeSH:Macular Degeneration Wet Macular Degeneration

1 Interventions

Name: PDS Implant with Ranibizumab 100 mg/mL

Description: Will be administered as per the schedule described in individual arm
Type: Drug
Group Labels: 4

PDS Implant Cohort 1 PDS Implant Cohort 2 PDS Implant Cohort 3 PDS Implant Cohort 4


Primary Outcomes

Measure: Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)

Time: Baseline up to Week 144

Measure: Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)

Time: Baseline up to Week 144

Measure: Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study

Time: Baseline up to Week 144

Secondary Outcomes

Description: 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.

Measure: Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters

Time: Baseline up to Week 144

Measure: Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time

Time: Baseline up to Week 144

Measure: Percentage of Participants with BCVA Score of 34 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time

Time: Baseline up to Week 144

Measure: Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time

Time: Baseline up to Week 144

Measure: Change from Baseline in Center Point Thickness Over Time

Time: Baseline up to Week 144

Measure: Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, and Fifth Refill Interval

Time: Weeks 16 to Week 136

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q24W

Extension Study for the Port Delivery System With Ranibizumab (Portal) This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refills administered every 24 weeks (Q24W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder) or Phase III Study GR40548 (Archway). --- Q24W ---



HPO Nodes