| Primary | Number of Subjects With Positive LUCENTIS® Retreatment Status at 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. | | Posted | | Count of Participants | | Participants | | Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Time to First LUCENTIS® Retreatment Need Identification up to Day 84 | The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS. | Extended PPS-A4 who required retreatment | Posted | | Count of Participants | | Participants | | Day 14, Day 28, Day 56, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Number of LUCENTIS® Retreatment Needs Identified Required 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 | | Posted | | Number | | participants | | Up to Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 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. | | Posted | | Count of Participants | | Participants | | Day 28, Day 56 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site | 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. | Extended PPS-A4. Missing data imputed using the Last Observation Carried Forward (LOCF) approach. | Posted | | Least Squares Mean | Standard Error | μm | | Day -1, Day 14, Day 28, Day 56, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site | 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. | Extended PPS-A4. Missing Data Imputed Using LOCF. | Posted | | Least Squares Mean | Standard Error | letters | | Day -1, Day 14, Day 28, Day 56, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit | 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. | Extended PPS-A4. Missing data imputed using LOCF. | Posted | | Mean | Standard Deviation | μm | | Day -1, Day 28, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Lesion Thickness by Visit | 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. | Extended PPS-A4. Missing data imputed using LOCF. | Posted | | Mean | Standard Deviation | μm | | Day -1, Day 28, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit | 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. | Extended PPS-A4. Missing Data Imputed Using LOCF. | Posted | | Mean | Standard Deviation | μm | | Day -1, Day 28, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit | 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. | Extended PPS-A4. Missing Data Imputed Using LOCF. | Posted | | Mean | Standard Deviation | μm | | Day -1, Day 28, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in Total Lesion Size by Visit | 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. | Extended PPS-A4 as observed | Posted | | Mean | Standard Deviation | mm^2 | | Day -1, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Change From Randomization Visit (Day -1) in CNV Size by Visit | 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. | Extended PPS-A4 as observed | Posted | | Mean | Standard Deviation | mm^2 | | Day -1, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. | | OG001 | Vehicle | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
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| Secondary | Plasma Concentration of LHA510 and CRA398 | Samples collected from subjects, after multiple topical ocular dosing of LHA510, were analyzed to determine concentrations of LHA510 and its metabolite, CRA398. Plasma LHA510 and CRA398 concentrations were quantitated by a validated liquid chromatography-tandem mass spectroscopy assay method. Below the limit of quantification (BLQ) is treated as zero. | This analysis population includes all subjects who were treated with LHA510, had at least 1 serum sample following exposure to the IP, and had no known specimen collection or analytical deviations, as identified by the Pharmacokineticist, that would have affected the integrity of the data [Pharmacokinetics (PK) Analysis Set]. | Posted | | Mean | Standard Deviation | ng/mL | | Day 28, Day 84 | | | | ID | Title | Description |
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| OG000 | LHA510 | LHA510 dose twice daily (BID) by Day 28, LHA510 dose once daily (QD) by Day 84, LHA510 dose 3-times daily (TID) by Day 84 | | OG001 | CRA398 | |
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