Overview

This trial is active, not recruiting.

Condition age-related macular degeneration; polypoidal choroidal vasculopathy (pcv)
Treatments ranibizumab, verteporfin pdt, sham pdt
Phase phase 4
Target VEGF
Sponsor Novartis Pharmaceuticals
Start date August 2013
End date April 2017
Trial size 321 participants
Trial identifier NCT01846273, CRFB002A2412

Summary

This study will compare the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin PDT on visual acuity in patients with symptomatic macular PCV. The results of this study will provide long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
After treatment initiation with combination therapy of ranibizumab and verteporfin PDT, re-treatment need with either ranibizumab alone or combined with verteporfin PDT will be determined at monthly visits based on defined retreatment criteria
ranibizumab
Intravitreal injections or 0.5 mg ranibizumab
verteporfin pdt
Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
(Active Comparator)
After treatment initiation with combination therapy of ranibizumab and sham PDT, re-treatment need with either ranibizumab alone or combined with sham PDT will be determined at monthly visits based on defined retreatment criteria.
ranibizumab
Intravitreal injections or 0.5 mg ranibizumab
sham pdt
Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)

Primary Outcomes

Measure
Change from Baseline in in Visual Acuity (Letters) of the Study Eye to Month 12
time frame: Baseline to Month 12
Complete polyp regression assessed by ICGA at Month 12
time frame: Month 12

Secondary Outcomes

Measure
Change from Baseline in Visual Acuity (Letters) of the Study Eye over time
time frame: Baseline to Month 24
Gain of equal or more than 5, 10, or 15 letters in Visual Acuity of the Study Eye up to Month 24
time frame: Baseline to Month 24
Loss of less than 5, 10, 15, and 30 letters in Visual Acuity in the Study Eye from baseline to Month 24
time frame: Baseline to Month 24
Maintenance of Visual Acuity of the Study Eye at Month 12 and 24 compared to the time point of first treatment interruption
time frame: Month 3 to Month 12 and 24
Change in Visual Acuity (Letters) of the Study Eye at Month 12 and 24 compared to the timepoint of first treatment interruption
time frame: Month 3 to Month 12 and 24
Occurrence of complete polyp regression in the Study Eye as assessed by ICGA at Months 6 and 24
time frame: Month 6 and 24
Presence of leakage in the Study Eye based on fluorescein angiography at Months 6, 12 and 24
time frame: Months 6,12, and
Change from Baseline in Central Subfield Retinal Thickness (CSRT) of the Study Eye over time
time frame: Baseline to Month 24
Total number of treatments with ranibizumab in the Study Eye and total number of treatments with verteporfin PDT from baseline to Month 12 and 24
time frame: Baseline to Month 12 and 24
Total number of treatments in the Study Eye with ranibizumab from Month 3 to Month 12 and 24
time frame: Month 3 to Month 12 and 24
National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores at baseline, Months 3, 12, and 24, and change from baseline over time
time frame: Baseline to Month 24
Frequency and severity of ocular and non-ocular adverse events over time
time frame: Screening to Month 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Confirmed diagnosis of symptomatic macular PCV in the study eye - A qualifying vision score at study entry - A qualifying lesion size in the study eye at study entry Exclusion Criteria: - Active inflammation or infection in the study eye - Uncontrolled intraocular pressure in the stuy eye - Ocular condition in the study eye which may impact vision and confound study outcomes - Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids

Additional Information

Official title A 24-month, Phase IV, Randomized, Double Masked, Multi-center Study of Ranibizumab Monotherapy or Ranibizumab in Combination With Verteporfin Photodynamic Therapy on Visual Outcome in Patients With Symptomatic Macular PCV
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Novartis.