18 and older, any sex, with Macular Edema or 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.
Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥10 LettersSecondary· Baseline, Month 3, 6, 8 and 11
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. Best value on the scale 100, worst 0. The number of participants maintaining ≥10 letters gains in BCVA (compared to the baseline BCVA \[Day 0\]) value for each visit from Month 3 onwards were reported.
Month 3
Group
Value
95% CI
Ranibizumab
8
Month 6
Group
Value
95% CI
Ranibizumab
4
Month 8
Group
Value
95% CI
Ranibizumab
3
Month 11
Group
Value
95% CI
Ranibizumab
1
Visual Acuity: Number of Participants Keeping a BCVA Score Gain ≥15 LettersSecondary· Baseline, Months 3, 6, 8 and 11
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. Best value on the scale 100, worst 0. The number of participants maintaining ≥15 letters gains in BCVA (compared to the baseline BCVA \[Day 0\]) value for each visit from Month 3 onwards were reported.
Month 3
Group
Value
95% CI
Ranibizumab
4
Month 6
Group
Value
95% CI
Ranibizumab
3
Month 8
Group
Value
95% CI
Ranibizumab
1
Month 11
Group
Value
95% CI
Ranibizumab
0
Visual Acuity: Number of Participants With a BCVA Loss ≥15 Letters at Months 8 and 11 Compared to Month 6 in the Study Eye.Secondary· Months 6, 8 and 11
Best-Corrected Visual Acuity (BCVA) letters were 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. Best value on the scale 100, worst 0. Number of participants presenting with a ≥15 letter loss in BCVA (compared to the value observed at 6 months) and leading to a treatment change (Rescue Group) for month 8 and 11 were analyzed.
Month 6 to Month 8
Group
Value
95% CI
Ranibizumab
0
Month 6 to Month 11
Group
Value
95% CI
Ranibizumab
0
Visual Acuity : Change of BCVA From Baseline in the Study Eye (ETDRS)Secondary· Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
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. Best value on the scale 100, worst 0. The mean variation in BCVA was compared to the baseline BCVA value \[Day 0\] over a period of 24 months for patients in the Main Group.
Month 1
Group
Value
95% CI
Ranibizumab
5.45
± 6.444
Month 2
Group
Value
95% CI
Ranibizumab
5.81
± 7.328
Month 3
Group
Value
95% CI
Ranibizumab
8.05
± 6.704
Month 4
Group
Value
95% CI
Ranibizumab
9.94
± 5.805
Month 5
Group
Value
95% CI
Ranibizumab
9.88
± 5.290
Month 6
Group
Value
95% CI
Ranibizumab
11.00
± 8.485
Month 8
Group
Value
95% CI
Ranibizumab
10.40
± 5.413
Month 11
Group
Value
95% CI
Ranibizumab
10.00
± NA
Central Retinal Thickness : Change of Log OCT From Baseline in the Study EyeSecondary· Baseline, months 1, 2, 3, 4, 5, 6, 8 and 11
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.The absolute variations of the Central Retinal Thickness (CRT) was measured using a Spectral Domain-Optical Coherence Tomography (SD-OCT) at each visit. Values were calculated as a log OCT (=log\[CRT/200\]).
Month 1
Group
Value
95% CI
Ranibizumab
-0.10
± 0.117
Month 2
Group
Value
95% CI
Ranibizumab
-0.12
± 0.122
Month 3
Group
Value
95% CI
Ranibizumab
-0.13
± 0.123
Month 4
Group
Value
95% CI
Ranibizumab
-0.13
± 0.104
Month 5
Group
Value
95% CI
Ranibizumab
-0.16
± 0.096
Month 6
Group
Value
95% CI
Ranibizumab
-0.15
± 0.120
Month 8
Group
Value
95% CI
Ranibizumab
-0.12
± 0.062
Month 11
Group
Value
95% CI
Ranibizumab
-0.13
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected from the patient screening onwards. However, a safety observation period which started from first injection until 4 weeks after discontinuation - up to 11 months..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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: 22 October 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/NCT02032173.