Clinical trial NCT03211234: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 76
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Retina Research Institute
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Retina Reseach Center
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: McAllen
country: United States
facility: Valley Retina Insititute
state: Texas
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Institute
city: Pasig City
country: Philippines
facility: The Medical City
city: Quezon City
country: Philippines
facility: St. Luke's Medical center Quezon City
Study officials:
References: