Phase 2
N=93
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
Exudative Age-Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02355028 ↗Enrolled (actual)
93
Serious AEs
0.6%
Results posted
Nov 2017
Primary outcome: Primary: Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84 — 25; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LHA510 ophthalmic suspension (Drug); LHA510 vehicle (Drug); Ranibizumab ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alcon, a Novartis Company
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84 |
25; 25 | — |
| SECONDARY Time to First LUCENTIS® Retreatment Need Identification up to Day 84 |
0; 0; 5; 8; 16; 11 | — |
| SECONDARY Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84 |
8; 12; 18; 18; 6; 6 | — |
| SECONDARY Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56 |
5; 8; 21; 19 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site |
-46.9; -43.0; -38.6; -28.9; 11.3; 1.0 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site |
1.3; 1.6; 1.7; 2.5; -0.5; 2.3 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit |
-16.6; -15.1; -4.1; -8.8 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Lesion Thickness by Visit |
-1.9; 6.9; 1.4; 6.9 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit |
-18.5; -11.0; -14.1; -5.9 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit |
-0.3; -13.3; -0.2; -7.6 | — |
| SECONDARY Change From Randomization Visit (Day -1) in Total Lesion Size by Visit |
-0.3; 0.5 | — |
| SECONDARY Change From Randomization Visit (Day -1) in CNV Size by Visit |
-0.6; 0.5 | — |
| SECONDARY Plasma Concentration of LHA510 and CRA398 |
0.0746; 0.0257; 0.0403; 0; 0.0694; 0.0160 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Sign written informed consent form;
- Wet AMD;
- IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose;
- BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye;
- Demonstrate ability to administer eye drops (subject or care-giver);
- CNV recently demonstrated high need for frequent anti-VEGF therapy and a sustained functional and clear anatomical response to the therapy in the study eye;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any active ocular or periocular infection or intraocular inflammation;
- Current or history of macular or retinal disease (if visually significant) other than wet AMD in the study eye;
- Current clinically significant vitreous hemorrhage or history of rhegmatogenous retinal detachment affecting the macula in the study eye;
- History of hypersensitivity to any of the study drugs or clinically relevant sensitivity to fluorescein dye or povidone iodine;
- Women of child-bearing potential;
- History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of investigational product;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02355028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.