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

Conditions

• Exudative Age-Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• LHA510 ophthalmic suspension — DRUG
• LHA510 vehicle — DRUG
  Inactive ingredients used as a placebo comparator
• Ranibizumab ophthalmic solution — DRUG
  For intravitreal (IVT) injection

Study Details

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).

Key Dates

First listed

Feb 4, 2015

Start date

Mar 3, 2015

Status verified

Nov 2017

Primary completion

Sep 15, 2016

Completion

Oct 18, 2016

Study Design

Enrollment

136 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84 [ Time Frame: Day 84 ]

Locations (1)

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