Age-Related Macular Degeneration
Conditions
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.
Interventions
DRUG2.0 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.
DRUG4.0 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.
DRUGLucentis
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Philippines, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Sham and Lucentis
Lucentis: Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis. | 17 |
| 2.0 mg DE-122 Low Dose DE-122 and Lucentis
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. | 31 |
| 4.0 mg DE-122 High Dose DE-122 and Lucentis
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. | 28 |
| Total | 76 |
Baseline characteristics
| Characteristic | Sham | 2.0 mg DE-122 | 4.0 mg DE-122 | Total |
|---|---|---|---|---|
| Age, Continuous | 75.4 years STANDARD_DEVIATION 9.18 | 72.1 years STANDARD_DEVIATION 7.34 | 75.6 years STANDARD_DEVIATION 9.84 | 74.1 years STANDARD_DEVIATION 8.79 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 9 Participants | 4 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 20 Participants | 24 Participants | 52 Participants |
| Region of Enrollment Philippines | 8 participants | 9 participants | 3 participants | 20 participants |
| Region of Enrollment United States | 9 participants | 22 participants | 25 participants | 56 participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 15 Participants | 41 Participants |
| Sex: Female, Male Male | 5 Participants | 17 Participants | 13 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 31 | 1 / 28 |
| other Total, other adverse events | 5 / 17 | 10 / 31 | 10 / 28 |
| serious Total, serious adverse events | 1 / 17 | 1 / 31 | 4 / 28 |
Outcome results
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.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 | 4.35 letters | Standard Deviation 8.937 |
| 2.0 mg DE-122 | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 | 0.87 letters | Standard Deviation 11.485 |
| 4.0 mg DE-122 | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 | -1.70 letters | Standard Deviation 10.55 |