Adults 50 to 90, any sex, with Exudative 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.
Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84Primary· Day 84
For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
Group
Value
95% CI
LHA510
25
Vehicle
25
Time to First LUCENTIS® Retreatment Need Identification up to Day 84Secondary· Day 14, Day 28, Day 56, Day 84
The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.
Day 14
Group
Value
95% CI
LHA510
0
Vehicle
0
Day 28
Group
Value
95% CI
LHA510
5
Vehicle
8
Day 56
Group
Value
95% CI
LHA510
16
Vehicle
11
Day 84
Group
Value
95% CI
LHA510
4
Vehicle
6
Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84Secondary· Up to Day 84
The number of LUCENTIS retreatment needs identified before or at the Day 84 visit (even if retreatment was applied at a later visit) for each patient was used in the analysis
0 retreatment injections
Group
Value
95% CI
LHA510
8
Vehicle
12
1 retreatment injection
Group
Value
95% CI
LHA510
18
Vehicle
18
2 retreatment injections
Group
Value
95% CI
LHA510
6
Vehicle
6
3 retreatment injections
Group
Value
95% CI
LHA510
1
Vehicle
1
Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56Secondary· Day 28, Day 56
The number of LUCENTIS® retreatment needs identified before or at the Day 28 and Day 56 visits (even if retreatment was applied at a later visit) for each subject was used in the analysis.
Day 28
Group
Value
95% CI
LHA510
5
Vehicle
8
Day 56
Group
Value
95% CI
LHA510
21
Vehicle
19
Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study SiteSecondary· Day -1, Day 14, Day 28, Day 56, Day 84
The thickness of the retina was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Day 14
Group
Value
95% CI
LHA510
-46.9
± 8.40
Vehicle
-43.0
± 7.93
Day 28
Group
Value
95% CI
LHA510
-38.6
± 7.42
Vehicle
-28.9
± 7.00
Day 56
Group
Value
95% CI
LHA510
11.3
± 10.01
Vehicle
1.0
± 9.45
Day 84
Group
Value
95% CI
LHA510
-16.8
± 8.92
Vehicle
-12.2
± 8.42
Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study SiteSecondary· Day -1, Day 14, Day 28, Day 56, Day 84
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using ETDRS charts and reported in number of letters read correctly. An increase (gain) in letters read from the baseline assessment indicates improvement. Only one eye (study eye) contributed to the analysis.
Day 14
Group
Value
95% CI
LHA510
1.3
± 0.80
Vehicle
1.6
± 0.75
Day 28
Group
Value
95% CI
LHA510
1.7
± 0.89
Vehicle
2.5
± 0.84
Day 56
Group
Value
95% CI
LHA510
-0.5
± 1.28
Vehicle
2.3
± 1.21
Day 84
Group
Value
95% CI
LHA510
-1.7
± 1.59
Vehicle
2.2
± 1.50
Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by VisitSecondary· Day -1, Day 28, Day 84
The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Day 28
Group
Value
95% CI
LHA510
-16.6
± 22.62
Vehicle
-15.1
± 38.21
Day 84
Group
Value
95% CI
LHA510
-4.1
± 35.34
Vehicle
-8.8
± 36.75
Change From Randomization Visit (Day -1) in Lesion Thickness by VisitSecondary· Day -1, Day 28, Day 84
The thickness of the neovascular lesion was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of the neovascular lesion may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Day 28
Group
Value
95% CI
LHA510
-1.9
± 38.05
Vehicle
6.9
± 43.66
Day 84
Group
Value
95% CI
LHA510
1.4
± 26.46
Vehicle
6.9
± 43.96
Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by VisitSecondary· Day -1, Day 28, Day 84
The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of subretinal fluid involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Day 28
Group
Value
95% CI
LHA510
-18.5
± 44.67
Vehicle
-11.0
± 34.73
Day 84
Group
Value
95% CI
LHA510
-14.1
± 54.08
Vehicle
-5.9
± 31.33
Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by VisitSecondary· Day -1, Day 28, Day 84
The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of pigment epithelial detachment involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Day 28
Group
Value
95% CI
LHA510
-0.3
± 38.92
Vehicle
-13.3
± 43.23
Day 84
Group
Value
95% CI
LHA510
-0.2
± 33.33
Vehicle
-7.6
± 47.25
Change From Randomization Visit (Day -1) in Total Lesion Size by VisitSecondary· Day -1, Day 84
The total wet AMD lesion size was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in wet AMD lesion size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Group
Value
95% CI
LHA510
-0.3
± 1.71
Vehicle
0.5
± 1.81
Change From Randomization Visit (Day -1) in CNV Size by VisitSecondary· Day -1, Day 84
The size of CNV (area of new blood vessels in the choroid layer of the retina) was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in CNV size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Group
Value
95% CI
LHA510
-0.6
± 2.00
Vehicle
0.5
± 1.71
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy of 84 successive days of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for recurrence of active choroidal neovascularization (CNV).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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 Alcon, a Novartis Company
Last refreshed: 2 July 2018
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/NCT02355028.