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Ranibizumab

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ranibizumab with Grid\&Direct short pulse laser photocoagulation

Ranibizumab is a biologic and known anti-VEGF (vascular endothelial growth factor) medication approved for treatment of ME (Macular Edema) due to RVO (Retinal Vein occlusion)

0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL, with or without laser treatment

Grid\&Direct short pulse laser photocoagulation is a kind of laser treatment to retina within vascular arcades and used to suppress macular edema

Grid&Direct short pulse laser photocoagulation

Novartis Pharmaceuticals

This is a Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study. The primary objective was assessed by the difference in the mean number of ranibizumab injections applied up to Month 11 between the 2 treatment arms. Patients were randomized in a 1:1 ratio to 1 of the 2 treatment arms; i.e. Arm 1 ranibizumab monotherapy, Arm 2 ranibizumab with Grid\&Direct short pulse laser photocoagulation combination therapy. There were 3 periods in this study: Screening Period (visit 1), Treatment Period (visit 2 to Visit 13) and Follow-up Period (visit 14). In addition to screening and Baseline (visit 2), there were monthly visits from Month 1 to Month 12. This study included male and female patients (≥20 years old) diagnosed with visual impairment due to ME secondary to BRVO.

Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study

Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety

A 12-month, Phase IV, Open-label, Randomized, Active Controlled, 2-arm, Multicenter Study Assessing the Efficacy and Safety of Intravitreal Ranibizumab Combined With Grid&Direct Short Pulse Laser Photocoagulation Versus a PRN Ranibizumab Monotherapy in Japanese Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Number of ranibizumab treatments from Day 1 to Month 11 using full analysis set (observed) based on a stratified Cochran-Mantel-Haenszel (CMH) test. Stratification was done based on categories of baseline decimal VA (\<0.3, or =\>0.3). Difference of mean number of injections, 95% confidence interval (CI) of difference and one-sided p-value of the CMH test was reported. Analysis was conducted within the FAS with observed data.

Stratification was based on baseline visual acuity on logMAR scale (\<0.52, \>=0.52). Test was one-sided.

Summary of BCVA (letters) absolute value and change from Baseline at Month 12 in the study eye - full analysis set (LOCF) was based on an analysis of variance (ANOVA) model with treatment group, and stratification factors. Stratification was done based on categories of baseline decimal VA (\<0.3, or =\>0.3). The analyses was conducted within the FAS using the LOCF approach

Stratification was based on baseline visual acuity on logMAR scale (\<0.52, \>=0.52). Test was one-sided.

Summary of BCVA (logMAR) absolute value and change from Baseline at Month 12 in the study eye - full analysis set (LOCF) was based on an analysis of variance (ANOVA) model with treatment group, and stratification factors. Stratification was based on baseline visual acuity (\< 0.52, \>= 0.52). The analyses was conducted within the FAS using the LOCF approach

Endpoints related to the number and proportion of patients with BCVA letter gain or loss from Baseline (Day1) was analyzed via stratified CMH test with stratification factors as described in primary model. The mean (SD) average (per patient) BCVA (logMAR) change from Baseline through Month 12

Summary of BCVA (logMAR) mean average change from Baseline from Month 1 through Month 12 in the study eye

The mean change in investigator-assessed CSFT from Month 1 through Month 12 was compared to Baseline (Day1) by the treatment arms. The analyses at each visit was based on an analysis of variance (ANOVA) model as analogous to BCVA. The analyses was conducted within the FAS using the Last-Observation-Carried-Forward (LOCF) approach

All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 12 months

0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL

Ranibizumab 0.5 mg

0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment.

Ranibizumab 0.5 mg+ Laser

Total

0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL with the laser treatment

Ranibizumab 0.5 mg and Laser

Age, Continuous

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Study Director

Ranibizumab 0.5 mg Laser

Randomized Set, i.e.; all randomized patients.

Difference in Mean Number of Ranibizumab Injections

baseline

month 12

change from baseline to month 12

The Full Analysis Set (FAS) consisted of all randomized patients who received at least one administration of ranibizumab injection.

The Mean Change in Best Corrected Visual Acuity (BCVA) Using Decimal Chart and Early Treatment Diabetic Retinopathy Study (ETDRS) Compared to Baseline

month12

The Mean Change in BCVA From Month 1 Through Month 12 Compared to Baseline (Day 1) by the Treatment Arms

Month 6 - BCVA improvement of >=1

month 6 - BCVA improvement of >=5

month 6 - BCVA improvement of >=10

Month 6 - BCVA improvement of >=15

Month 6 - BCVA improvement of >=30

month 6 Score >=73

month 6 Score >=80

month 6 Score >=85

month 6 loss of <15

Month 12 - BCVA improvement of >=1

Month 12 - BCVA improvement of >=5

Month 12 - BCVA improvement of >=10

Month 12 - BCVA improvement of >=15

Month 12 - BCVA improvement of >=30

month 12 Score >=73

month 12 Score >=80

month 12 Score >=85

month 12 Loss of <15

Full Analysis Set (FAS) consisted of all randomized patients who received at least one administration of ranibizumab injection

BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety	NCT02953938	Macular Edema S...	Ranibizumab Grid&Direct sho...	20 Years -	Novartis
Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety	NCT02953938	Macular Edema S...	Ranibizumab Grid&Direct sho...	20 Years -	Novartis
Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety	NCT02953938	Macular Edema S...	Ranibizumab Grid&Direct sho...	20 Years -	Novartis

Spots Global Cancer Trial Database for macular edema secondary to branch retinal vein occlusion (brvo)