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
CompletedPhase 4Results postedLast updated 25 February 2020
What this trial tests
Phase 4 trial testing Ranibizumab in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) in 59 participants. Completed in 28 December 2018.
20 and older, any sex, with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in Mean Number of Ranibizumab InjectionsPrimary· Month 1 through Month 12
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.
Group
Value
95% CI
Ranibizumab 0.5 mg
4.3
± 2.51
Ranibizumab 0.5 mg Laser
4.1
± 2.41
The Mean Change in Best Corrected Visual Acuity (BCVA) Using Decimal Chart and Early Treatment Diabetic Retinopathy Study (ETDRS) Compared to BaselineSecondary· Month 1 through Month 12 (for ETDRS: Month 6 and Month 12)
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.
baseline
Group
Value
95% CI
Ranibizumab 0.5 mg
52.86
± 13.384
Ranibizumab 0.5 mg Laser
54.03
± 9.828
month 12
Group
Value
95% CI
Ranibizumab 0.5 mg
74.83
± 9.740
Ranibizumab 0.5 mg Laser
69.59
± 8.842
change from baseline to month 12
Group
Value
95% CI
Ranibizumab 0.5 mg
21.97
± 14.749
Ranibizumab 0.5 mg Laser
15.00
± 10.296
The Mean Change in BCVA From Month 1 Through Month 12 Compared to Baseline (Day 1) by the Treatment ArmsSecondary· Month 1 through Month 12
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
baseline
Group
Value
95% CI
Ranibizumab 0.5 mg
0.553
± 0.2276
Ranibizumab 0.5 mg Laser
0.558
± 0.1719
month12
Group
Value
95% CI
Ranibizumab 0.5 mg
0.075
± 0.1909
Ranibizumab 0.5 mg Laser
0.143
± 0.1682
change from baseline to month 12
Group
Value
95% CI
Ranibizumab 0.5 mg
-0.478
± 0.2586
Ranibizumab 0.5 mg Laser
-0.413
± 0.1969
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 EyeSecondary· Month 6 and Month 12
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
Month 6 - BCVA improvement of >=1
Group
Value
95% CI
Ranibizumab 0.5 mg
27
Ranibizumab 0.5 mg Laser
24
month 6 - BCVA improvement of >=5
Group
Value
95% CI
Ranibizumab 0.5 mg
26
Ranibizumab 0.5 mg Laser
21
month 6 - BCVA improvement of >=10
Group
Value
95% CI
Ranibizumab 0.5 mg
22
Ranibizumab 0.5 mg Laser
16
Month 6 - BCVA improvement of >=15
Group
Value
95% CI
Ranibizumab 0.5 mg
17
Ranibizumab 0.5 mg Laser
12
Month 6 - BCVA improvement of >=30
Group
Value
95% CI
Ranibizumab 0.5 mg
4
Ranibizumab 0.5 mg Laser
1
month 6 Score >=73
Group
Value
95% CI
Ranibizumab 0.5 mg
12
Ranibizumab 0.5 mg Laser
10
month 6 Score >=80
Group
Value
95% CI
Ranibizumab 0.5 mg
8
Ranibizumab 0.5 mg Laser
2
month 6 Score >=85
Group
Value
95% CI
Ranibizumab 0.5 mg
3
Ranibizumab 0.5 mg Laser
1
The Mean Change in Change in Central Subfield Foveal Thickness (CSFT) From Month 1 Through Month 12 Compared to Baseline (Day1) by the Treatment ArmsSecondary· Month 1 through Month 12
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
baseline
Group
Value
95% CI
Ranibizumab 0.5 mg
563.3
± 146.92
Ranibizumab 0.5 mg Laser
553.3
± 182.39
month 12
Group
Value
95% CI
Ranibizumab 0.5 mg
257.0
± 43.44
Ranibizumab 0.5 mg Laser
285.1
± 82.80
change in baseline from month 12
Group
Value
95% CI
Ranibizumab 0.5 mg
-306.3
± 164.35
Ranibizumab 0.5 mg Laser
-261.3
± 180.23
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ranibizumab 0.5 mg
Serious: 1/29 (3%)
Deaths: 0/29
Ranibizumab 0.5 mg+ Laser
Serious: 2/30 (7%)
Deaths: 0/30
Total
Serious: 3/59 (5%)
Deaths: 0/59
Serious adverse events (3 terms)
Reaction
System
Ranibizumab 0.5 mg
Ranibizumab 0.5 mg+ Laser
Total
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
· Phase 3
· recruiting
NCT06957080 — A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
· Phase 2, PHASE3
· active not recruiting
NCT06176352 — A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Path
· Phase 3
· active not recruiting
NCT05126966 — A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Afl
· Phase 3
· withdrawn
NCT05480293 — This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab
· Phase 3
· unknown
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 25 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02953938.