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Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

NCT03211234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-07-13

Study results available
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Summary

To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.

Conditions

  • Age-Related Macular Degeneration

Interventions

DRUG

2.0 mg DE-122 Injectable Solution + Lucentis

Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.

DRUG

4.0 mg DE-122 Injectable Solution + Lucentis

Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.

DRUG

Lucentis

Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.

Sponsors & Collaborators

  • Santen Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2019-12-31
Completion
2020-01-31
FDA Drug
Yes

Countries

  • United States
  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03211234 on ClinicalTrials.gov