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 Polypoidal Choroidal Vasculopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye
研究概览
简要总结
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.
详细描述
Patients were randomized to the study in 2 treatment groups: ranibizumab + vPDT combination therapy, and ranibizumab monotherapy. Based on the results of the primary analysis at Month 12, patients still in the ranibizumab monotherapy group at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit. A total of 168 and 154 patients were included in the ranibizumab + vPDT combined therapy and ranibizumab monotherapy groups, respectively for the FAS (Month 12 analysis). However, the safety set included 172 and 149 patients, respectively. Four patients in the combination therapy group never took vPDT . Among them, 1 patient actually received verteporfin injection but no laser injection. Thus a total of 3 patients (4-1) in the combination therapy group did not take the actual full vPDT treatment. Additionally, 7 patients in the monotherapy group received vPDT and 1 patient from the monotherapy group did not receive ranibizumab treatment. Considering the above numbers, safety set included 172 patients (i.e., 168-3+7) in the ranibizumab + vPDT combination therapy group and 149 patients (i.e., 154-7+3-1) in the ranibizumab monotherapy group for Month 12 analysis. For the Month 24 safety analysis, the 14 patients in the ranibizumab monotherapy group who were switched to ranibizumab +vPDT combination therapy group were analyzed as a separate group, ie, ranibizumab 0.5 mg + vPDT (switched).
.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ranibizumab + vPDT
Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) determined at monthly visits based on defined retreatment criteria
干预措施: Ranibizumab (Drug)
Ranibizumab + vPDT
Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) determined at monthly visits based on defined retreatment criteria
干预措施: Verteporfin PDT (Drug)
Ranibizumab monotherapy
Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) determined at monthly visits based on defined retreatment criteria
干预措施: Ranibizumab (Drug)
Ranibizumab monotherapy
Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) determined at monthly visits based on defined retreatment criteria
干预措施: Sham PDT (Drug)
结局指标
主要结局
Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye
时间窗: Baseline, Month 12
Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye
时间窗: Baseline, Month 12
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.
次要结局
- Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption(Month 3, Month 12, Month 24)
- Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24(Baseline, Month 24)
- Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24(Month 3, Month 24)
- Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye(Baseline, Month 24)
- Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye(Month 6, Month 24)
- Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye(Month 6, Month 12 and Month 24)
- Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye(Baseline, Month 24)
- Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12(Baseline, Month 12)
- Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24(Baseline, Month 24)
- Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class(Up to Month 24)
- Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12(Month 3, Month 12)
- Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye(Baseline, Month 24)
- Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption(Month 3, Month 12, Month 24)
- Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12(Baseline, Month 12)
- Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class(Up to Month 24)
- Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24(Baseline, Month 3, Month 12, Month 24)