Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM) Clinical Trial
— BrillianceOfficial 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
Verified date | March 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 457 |
Est. completion date | September 14, 2016 |
Est. primary completion date | September 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Novartis Investigative Site | Beijing | Beijing |
China | Novartis Investigative Site | Beijing | Beijing |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Beijing | |
China | Novartis Investigative Site | Changsha | Hunan |
China | Novartis Investigative Site | Changsha | Hunan |
China | Novartis Investigative Site | Chengdu | Sichuan |
China | Novartis Investigative Site | Chongqing | Chongqing |
China | Novartis Investigative Site | Chongqing | |
China | Novartis Investigative Site | Hangzhou | Zhejiang |
China | Novartis Investigative Site | Harbin | Heilongjiang |
China | Novartis Investigative Site | Nanchang | Jiangxi |
China | Novartis Investigative Site | Nanjing | Jiangsu |
China | Novartis Investigative Site | Nanjing | Jiangsu |
China | Novartis Investigative Site | Qingdao | Shandong |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shanghai | |
China | Novartis Investigative Site | Shantou | Guangdong |
China | Novartis Investigative Site | Tianjin | Tianjin |
China | Novartis Investigative Site | Tianjin | Tianjin |
China | Novartis Investigative Site | Wenzhou | Zhejiang |
China | Novartis Investigative Site | Wu XI | Jiangsu |
China | Novartis Investigative Site | Wuhan | Hubei |
China | Novartis Investigative Site | Wuhan | Hubei |
China | Novartis Investigative Site | Xi'an | Shanxi |
Hong Kong | Novartis Investigative Site | Hongkong | |
India | Novartis Investigative Site | Angamaly | |
India | Novartis Investigative Site | Bangalore | Karnataka |
India | Novartis Investigative Site | Bhubaneswar | Orissa |
India | Novartis Investigative Site | Chandigarh | Haryana |
India | Novartis Investigative Site | Chennai | Tamil Nadu |
India | Novartis Investigative Site | Chennai | Tamil Nadu |
India | Novartis Investigative Site | Coimbatore | Tamil Nadu |
India | Novartis Investigative Site | Hyderabad | Telangana |
India | Novartis Investigative Site | New Delhi | |
India | Novartis Investigative Site | Vanchiyoor | Kerala |
Korea, Republic of | Novartis Investigative Site | Pusan | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Philippines | Novartis Investigative Site | Manila | Metro Manila |
Philippines | Novartis Investigative Site | Manila | Metro Manila |
Thailand | Novartis Investigative Site | Bangkok | |
Thailand | Novartis Investigative Site | Chiang Mai | |
Thailand | Novartis Investigative Site | Khon Kaen | THA |
Thailand | Novartis Investigative Site | Nakornphathom |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
China, Hong Kong, India, Korea, Republic of, Philippines, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. | From Baseline to Month 3 | |
Secondary | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6. |
From Baseline to Month 6 | |
Secondary | The Average Change in BCVA Score From Baseline to Month 1 Through Month 12 | Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 12 |
From Baseline to Month 12 | |
Secondary | Mean Change From Baseline in Visual Acuity Over Time | Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. | Change from baseline at months 3, 6, and 12 | |
Secondary | Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye | ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. | From Baseline to Month 12 | |
Secondary | Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT) | Central sub-field thickness (CSFT) is a variable assessed via Optical Coherence Tomography (OCT). OCT was performed prior to any study drug administration to assess presence of intra, subretinal fluid, or increase of CSFT. | Baseline, Month 3, Month 6, and Month 12 | |
Secondary | Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12 | CNV leakage is assessed via fluorescein angiography (center involvement) category: definite, questionable, absent, can't grade, and missing. | From Baseline until Month 12 | |
Secondary | NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12 | The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning. | Change from baseline at month 3, 6 and 12 | |
Secondary | Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups | To assess treatment pattern with ranibizumab | From Baseline to Month 12 |