Phase 4
N=322
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)
Age-related Macular Degeneration · Polypoidal Choroidal Vasculopathy
Bottom Line
View on ClinicalTrials.gov: NCT01846273 ↗Enrolled (actual)
322
Serious AEs
16.2%
Results posted
Jun 2019
Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye — 8.3; 5.1 Letters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ranibizumab (Drug); Verteporfin PDT (Drug); Sham PDT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye |
8.3; 5.1 | <0.001 sig |
| PRIMARY Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye |
115; 52 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye |
9.7; 5.4; 6.1 | — |
| SECONDARY Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye |
74.0; 57.5; 51.2; 51.4; 36.8; 43.9 | — |
| SECONDARY Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption |
— | — |
| SECONDARY Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption |
— | — |
| SECONDARY Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye |
100; 100; 100; 71.3; 30.4; 22.0 | — |
| SECONDARY Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye |
100; 100; 100; 43; 73.5; 78 | — |
| SECONDARY Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye |
401.6; 390; 412.5; 248.8; 294.5; 273.8 | — |
| SECONDARY Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12 |
887; 1089 | — |
| SECONDARY Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12 |
264; 345 | — |
| SECONDARY Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 |
1422; 1625; 225 | — |
| SECONDARY Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 |
389; 459; 81 | — |
| SECONDARY Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12 |
378; 651 | — |
| SECONDARY Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 |
913; 1229; 183 | — |
| SECONDARY Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 |
76.5; 75.9; 80.9; 79.4; 80.5; 82.5 | — |
| SECONDARY Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class |
55; 31; 7; 7; 11; 1 | — |
| SECONDARY Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class |
65; 49; 6; 17; 17; 2 | — |
Summary
This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01846273). 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.