Exudative Age-Related Macular DegenerationPhase 2NCT02355028
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
A Phase 2 study testing LHA510 ophthalmic suspension and Ranibizumab ophthalmic solution in people with Exudative Age-Related Macular Degeneration, run by Alcon, a Novartis Company at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- What is being tested?
- LHA510 ophthalmic suspension and Ranibizumab ophthalmic solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2015to 18 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: A Randomized, Double-Masked, Vehicle-Controlled Proof-Of-Concept Study for Topically Delivered LHA510 as a Maintenance Therapy in Patients With Wet Age-Related Macular Degeneration (AMD)
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).
Read the detailed description
On Day -1, patients will receive an IVT Lucentis® injection in the study eye, and then will be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1 ratio for 84 days. Patients with recurrence of active CNV in the study eye during the study will receive rescue IVT Lucentis® injections. Following the treatment period, subjects will return for a follow-up visit and a disposition visit. Only one eye (designated as the study eye) will be dosed with either topical LHA510 or vehicle per patient.
- Being tested
- LHA510 ophthalmic suspension, LHA510 vehicle, Ranibizumab ophthalmic solution
- Keywords
- LHA510, PoC, Age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHA510 ophthalmic suspensionDrug
LHA510 vehicleDrug
Inactive ingredients used as a placebo comparator
Ranibizumab ophthalmic solutionDrug
Also called Lucentis®
For intravitreal (IVT) injection
| Study group | Role | What they receive |
|---|---|---|
| LHA510 | Experimental | 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. Receives: Drug: LHA510 ophthalmic suspension; Drug: Ranibizumab ophthalmic solution |
| Vehicle | Placebo comparator | 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. Receives: Drug: LHA510 vehicle; Drug: Ranibizumab ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 84
Secondary outcomes (12)
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.
Measured: Day 14, Day 28, Day 56, Day 84
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
Measured: Up to Day 84
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.
Measured: Day 28, Day 56
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.
Measured: Day -1, Day 14, Day 28, Day 56, Day 84
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.
Measured: Day -1, Day 14, Day 28, Day 56, Day 84
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.
Measured: Day -1, Day 28, Day 84
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.
Measured: Day -1, Day 28, Day 84
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.
Measured: Day -1, Day 28, Day 84
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.
Measured: Day -1, Day 28, Day 84
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.
Measured: Day -1, Day 84
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.
Measured: Day -1, Day 84
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.
Measured: Day 28, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start3 Mar 2015
- Primary completion15 Sep 2016
- Study completion18 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exudative Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon, a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Scientist, CA CSI, ID/Multi-TA, Study director, Novartis Institutes for BioMedical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355028
- Sponsor's protocol ID
- LHA510-2201
- Status last verified
- Nov 2017
- First submitted
- 28 Jan 2015
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Vehicle-Controlled Proof-Of-Concept Study for Topically Delivered LHA510 as a Maintenance Therapy in Patients With Wet Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT02355028
- Acronym / sponsor ID
- LHA510-2201
- Keywords
- LHA510, PoC, Age-related macular degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 18 Oct 2016 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Posted 14 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
On Day -1, patients will receive an IVT Lucentis® injection in the study eye, and then will be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1 ratio for 84 days. Patients with recurrence of active CNV in the study eye during the study will receive rescue IVT Lucentis® injections. Following the treatment period, subjects will return for a follow-up visit and a disposition visit. Only one eye (designated as the study eye) will be dosed with either topical LHA510 or vehicle per patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LHA510 | Experimental | Drug: LHA510 ophthalmic suspension, Drug: Ranibizumab ophthalmic solutionLHA510 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. |
| Vehicle | Placebo comparator | Drug: LHA510 vehicle, Drug: Ranibizumab ophthalmic solutionLHA510 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHA510 ophthalmic suspension | Drug | LHA510 |
| LHA510 vehicleInactive ingredients used as a placebo comparator | Drug | Vehicle |
| Ranibizumab ophthalmic solutionAlso: Lucentis®For intravitreal (IVT) injection | Drug | LHA510, Vehicle |
Primary outcome
Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84
Time frame: 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.
12 secondary outcomes
Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Time frame: Day 14, Day 28, Day 56, Day 84
Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
Time frame: Up to Day 84
Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56
Time frame: Day 28, Day 56
Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Time frame: Day -1, Day 14, Day 28, Day 56, Day 84
Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Time frame: Day -1, Day 14, Day 28, Day 56, Day 84
Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit
Time frame: Day -1, Day 28, Day 84
Change From Randomization Visit (Day -1) in Lesion Thickness by Visit
Time frame: Day -1, Day 28, Day 84
Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit
Time frame: Day -1, Day 28, Day 84
Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit
Time frame: Day -1, Day 28, Day 84
Change From Randomization Visit (Day -1) in Total Lesion Size by Visit
Time frame: Day -1, Day 84
Change From Randomization Visit (Day -1) in CNV Size by Visit
Time frame: Day -1, Day 84
Plasma Concentration of LHA510 and CRA398
Time frame: Day 28, Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Scientist, CA CSI, ID/Multi-TA study director
Novartis Institutes for BioMedical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LHA510 ophthalmic suspension and Ranibizumab ophthalmic solution in people with Exudative Age-Related Macular Degeneration, run by Alcon, a Novartis Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84 (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.