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 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 36-002
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 14

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

2.0 mg DE-122

EXPERIMENTAL

2.0 mg DE-122 and Lucentis ® 0.5 mg

Drug: 2.0 mg DE-122 Injectable Solution + Lucentis

4.0 mg DE-122

EXPERIMENTAL

4.0 mg DE-122 and Lucentis ® 0.5 mg

Drug: 4.0 mg DE-122 Injectable Solution + Lucentis

Sham

SHAM COMPARATOR

Sham and Lucentis ® 0.5 mg

Drug: Lucentis

Interventions

2.0 mg DE-122 Injectable Solution + Lucentis DRUG

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

2.0 mg DE-122

4.0 mg DE-122 Injectable Solution + Lucentis DRUG

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

4.0 mg DE-122

Lucentis DRUG

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

Sham

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \[Ocular\]
• 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

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (14)

Retina Research Institute

Gilbert, Arizona, 85296, United States

Location

Retina-Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Reseach Center

Austin, Texas, 78705, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Valley Retina Insititute

McAllen, Texas, 78503, United States

Location

Asian Eye Institute

Makati City, Philippines

Location

Peregrine Eye and Laser Institute

Makati City, Philippines

Location

The Medical City

Pasig, Philippines

Location

St. Luke's Medical center Quezon City

Quezon City, Philippines

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: R&D Quality Manager
• Organization: Santen Inc

clinicaltrials@santen.com

+1 415 268 9199

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 7, 2017
• Study Start: July 5, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Locations

US (10); PH (4)