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

Phase 2

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: 2.0 mg DE-122 Injectable Solution + Lucentis; Drug: Lucentis; Drug: 4.0 mg DE-122 Injectable Solution + Lucentis

• Registration Number: NCT03211234
• Lead Sponsor: Santen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-05
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Disposition First Submitted: 2020-09-28
• Disposition First Submitted QC: 2020-09-28
• Disposition First Posted: 2020-10-05
• Status Verified: 2021-06
• Results First Submitted: 2021-06-22
• Results First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Results First Posted: 2021-07-13
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.0 mg DE-122	2.0 mg DE-122 Injectable Solution + Lucentis	2.0 mg DE-122 and Lucentis ® 0.5 mg
Sham	Lucentis	Sham and Lucentis ® 0.5 mg
4.0 mg DE-122	4.0 mg DE-122 Injectable Solution + Lucentis	4.0 mg DE-122 and Lucentis ® 0.5 mg

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24	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.

Trial Locations

Locations (14)

Retina Research Institute; 🇺🇸 Gilbert, Arizona, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Retina-Vitreous Associates; 🇺🇸 Beverly Hills, California, United States

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

Colorado Retina Associates; 🇺🇸 Golden, Colorado, United States

National Ophthalmic Research Institute; 🇺🇸 Fort Myers, Florida, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Retina Reseach Center; 🇺🇸 Austin, Texas, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

Asian Eye Institute; 🇵🇭 Makati City, Philippines

Valley Retina Insititute; 🇺🇸 McAllen, Texas, United States

Peregrine Eye and Laser Institute; 🇵🇭 Makati City, Philippines

The Medical City; 🇵🇭 Pasig City, Philippines

St. Luke's Medical center Quezon City; 🇵🇭 Quezon City, Philippines