LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

NCT02355028 | Completed Phase 2 Results

• 1 other identifier: LHA510-2201
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Exudative Age-Related Macular Degeneration

Keywords

LHA510; PoC; Age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 84

Secondary Outcomes (12)

• Time to First LUCENTIS® Retreatment Need Identification up to Day 84

  Day 14, Day 28, Day 56, Day 84

• Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84

  Up to Day 84

• Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56

  Day 28, Day 56

• Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site

  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

  Day -1, Day 14, Day 28, Day 56, Day 84

Study Arms (2)

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.

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.

Drug: LHA510 vehicle; Drug: Ranibizumab ophthalmic solution

Interventions

LHA510 ophthalmic suspension DRUG

LHA510

LHA510 vehicle DRUG

Inactive ingredients used as a placebo comparator

Vehicle

Ranibizumab ophthalmic solution DRUG

For intravitreal (IVT) injection

Also known as: Lucentis®

LHA510; Vehicle

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

acrizanib; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Scientist, NIBR
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Scientist, CA CSI, ID/Multi-TA

  Novartis Institutes for BioMedical Research, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 4, 2015
• Study Start: March 3, 2015
• Primary Completion: September 15, 2016
• Study Completion: October 18, 2016
• Last Updated: July 2, 2018
• Results First Posted: November 14, 2017

Record last verified: 2017-11

Locations

US (1)