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

Age-Related Macular Degeneration Clinical Trial

Official title:

A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211234
• Other study ID #: 36-002
• Status: Completed
• Phase: Phase 2
• Start date: July 5, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Provide signed written informed consent

• Diagnosis of active choroidal neovascularization secondary to wet AMD

• BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye

• BCVA of 25 ETDRS letters (20/320) or better in the fellow eye

Exclusion Criteria:

[Ocular]

• Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1 and throughout the study

• Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye

• Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study

• Need for ocular surgery in the study eye during the course of the study

• Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform examinations

[Non-ocular]

• Allergy or hypersensitivity to study drug product, fluorescein dye or other study related procedures and medications

• Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study

• Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study

• Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study

• Unable to comply with study procedures or follow-up visits

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Philippines	Asian Eye Institute	Makati City
Philippines	Peregrine Eye and Laser Institute	Makati City
Philippines	The Medical City	Pasig City
Philippines	St. Luke's Medical center Quezon City	Quezon City
United States	Retina Reseach Center	Austin	Texas
United States	Retina-Vitreous Associates	Beverly Hills	California
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Retina Research Institute	Gilbert	Arizona
United States	Colorado Retina Associates	Golden	Colorado
United States	Retina Consultants of Houston	Houston	Texas
United States	Valley Retina Insititute	McAllen	Texas
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Bay Area Retina Associates	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Countries where clinical trial is conducted

United States,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24	BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint.; An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision.	Week 24