18 and older, any sex, with Retinal Vein Occlusion or Age Related Macular Degeneration. 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.
Mean Change From Baseline in Best Correct Visual Acuity (BCVA)Primary· baseline, week 48
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
Group
Value
95% CI
Ranibizumab
9.55
± 6.57
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36Secondary· Baseline, Week 4, 8, 12, 24 and 36
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Week 4
Group
Value
95% CI
Ranibizumab
5.65
± 5.25
Week 8
Group
Value
95% CI
Ranibizumab
6.90
± 4.27
Week 12
Group
Value
95% CI
Ranibizumab
8.50
± 6.13
Week 24
Group
Value
95% CI
Ranibizumab
8.05
± 7.32
Week 36
Group
Value
95% CI
Ranibizumab
8.40
± 7.18
Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)Secondary· Baseline, week 48
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Right eye
Group
Value
95% CI
Ranibizumab
388.50
± 151.39
Left eye
Group
Value
95% CI
Ranibizumab
367.06
± 91.44
Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.Secondary· Week 48
Group
Value
95% CI
Ranibizumab
7
Number of Participants With Letters Gain / Loss at Week 52Secondary· Baseline, Week 52
Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
5 or more letters gained
Group
Value
95% CI
Ranibizumab
14
10 or more letters gained
Group
Value
95% CI
Ranibizumab
8
15 or more letters gained
Group
Value
95% CI
Ranibizumab
5
5 or more letters lost
Group
Value
95% CI
Ranibizumab
0
10 or more letters lost
Group
Value
95% CI
Ranibizumab
0
15 or more letters lost
Group
Value
95% CI
Ranibizumab
0
Change in Mean Visual Function Questionnaire (VFQ-25)Secondary· Baseline, week 48
"Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening."
General health
Group
Value
95% CI
Ranibizumab
12.50
± 28.68
General vision
Group
Value
95% CI
Ranibizumab
13
± 14.90
Ocular pain
Group
Value
95% CI
Ranibizumab
11.88
± 23.81
Near activities
Group
Value
95% CI
Ranibizumab
7.50
± 16.64
Distance activities
Group
Value
95% CI
Ranibizumab
9.62
± 16.26
Social Functioning
Group
Value
95% CI
Ranibizumab
13.13
± 15.95
Mental health
Group
Value
95% CI
Ranibizumab
9.69
± 31.90
Role difficulties
Group
Value
95% CI
Ranibizumab
10.63
± 34.24
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to 14 months..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration.
Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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: 20 February 2019
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/NCT02140411.