Clinical trial NCT01922102: Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Official title: A 12-month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Individualized Regimens of 0.5mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)
Keywords: vision loss,PM,CNV,ranibizumab,verteporfinPDT,Brilliance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (PM)

Detailed description: This was a phase III, multi-center, randomized, double-masked, active-controlled study comparing 0.5 mg ranibizumab vs. vPDT therapy. The study included 15 scheduled visits over 12 months, and there were to be two additional visits (2a, 3a) for subset of patients in whom PK analysis were performed.

There were 3 periods in this study: Screening period-from Day -14 to Baseline; Treatment period-from Baseline to Month 11; Follow-up period-from Month 11 to Month 12 Patients entered the 11 months Treatment period at Visit 2 (Day 1) if eligibility criteria were met and were randomized in three treatment groups Group I ranibizumab 0.5 mg driven by VA stability criteria or Group II ranibizumab 0.5 mg driven by disease activity criteria or Group III vPDT (randomization ratio of 2:2:1) and received first treatment of either a ranibizumab injection and sham vPDT or sham injection and active vPDT and will return to the clinical center within 7 days to undergo safety assessments as well as assessments of the effect of treatment by the evaluating investigator. The following visits were performed at one month intervals starting at Visit 4 and continuing through Visit 14. At all monthly visits (at/from Month 2 for group I, at/from Month 1 for group II and at/from Month 3 for group III) the decision for treatment were made by the evaluating investigator based on the VA stability criteria and on the disease activity criteria. At Month 3 (visit 6) and at all following monthly visits for all three groups one of the three options can recommended by evaluating investigator: a) ranibizumab 0.5 mg, b) ranibizumab 0.5 mg + vPDT; c) vPDT. The treating investigator were then perform treatment based on randomization and masking requirements.

At each monthly visit, patients had a safety evaluation by the evaluating investigator prior to study treatment, consisting of visual acuity measurements, ophthalmic examinations and evaluation of adverse events and vital signs. Routine hematology, chemistry, and urinalysis profiles were obtained at Visit 6, 9 and 12 (Month 3, 6 and 9). At Month 12 several procedures and assessments were performed which are required at study completion visit.

Eligibility criteria: Inclusion Criteria:

* Visual impairment due to CNV secondary to PM.
* Best corrected visual acuity in the study eye \> 24 and \< 78 ETDRS letters.
* High myopia (\> -6D),
* anterio-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia.
* Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.

Exclusion Criteria:

* Some preexisting eye disorders or systemic diseases;-Blood pressure \> 150/90 mmHg
* Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or verteporfin PDT in the study eye
* Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Primary outcomes:
measure: Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3
timeFrame: From Baseline to Month 3
Secondary outcomes:
measure: Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6
timeFrame: From Baseline to Month 6
measure: The Average Change in BCVA Score From Baseline to Month 1 Through Month 12
timeFrame: From Baseline to Month 12
measure: Mean Change From Baseline in Visual Acuity Over Time
timeFrame: Change from baseline at months 3, 6, and 12
measure: Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye
timeFrame: From Baseline to Month 12
measure: Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)
timeFrame: Baseline, Month 3, Month 6, and Month 12
measure: Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12
timeFrame: From Baseline until Month 12
measure: NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12
timeFrame: Change from baseline at month 3, 6 and 12
measure: Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups
timeFrame: From Baseline to Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Shantou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Wu XI
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Qingdao
country: China
facility: Novartis Investigative Site
state: Shandong
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Hongkong
country: Hong Kong
facility: Novartis Investigative Site
city: Chandigarh
country: India
facility: Novartis Investigative Site
state: Haryana
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Vanchiyoor
country: India
facility: Novartis Investigative Site
state: Kerala
city: Bhubaneswar
country: India
facility: Novartis Investigative Site
state: Orissa
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Angamaly
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Nakornphathom
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: