Age-Related Macular Degeneration
Conditions
Keywords
Macular Degeneration
Brief summary
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
Interventions
DRUG0.5 mg of DE-122
DE-122 Injectable Solution
DRUG1.0 mg of DE-122
DE-122 Injectable Solution
DRUG2.0 mg of DE-122
DE-122 Injectable Solution
DRUG4.0 mg of DE-122
DE-122 Injectable Solution
Sponsors
Santen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide signed written informed consent * Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration * Prior treatment in the study eye with any intravitreal anti-VEGF medication * At least one lesion in the study eye that meets minimal pathology criteria * Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye * Best corrected visual acuity of 20/200 or better in the fellow eye * Reasonably clear media and some fixation in the study 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 * 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 required study assessments in either eye and/or confound study results 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 |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | Baseline (Day1) and Day 90. | BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Subfield Thickness (CST) at Day 90. | Baseline (Day1) and Day 90. | Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.5 mg of DE-122 Single intravitreal injection of Low Dose DE-122 Injectable Solution | 3 |
| 1.0 mg of DE-122 Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution | 3 |
| 2.0 mg of DE-122 Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution | 3 |
| 4.0 mg of DE-122 Single intravitreal injection of High Dose DE-122 Injectable Solution | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | 2.0 mg of DE-122 | 4.0 mg of DE-122 | Total | 0.5 mg of DE-122 | 1.0 mg of DE-122 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 11 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 74.0 years STANDARD_DEVIATION 6.2 | 84.0 years STANDARD_DEVIATION 7.2 | 74.3 years STANDARD_DEVIATION 8.1 | 65.7 years STANDARD_DEVIATION 4.2 | 73.7 years STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 11 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 7 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 5 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 2 / 3 | 2 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
Time frame: Baseline (Day1) and Day 90.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5 mg of DE-122 | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | -1.3 ETDRS letters | Standard Deviation 2.1 |
| 1.0 mg of DE-122 | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | 2.7 ETDRS letters | Standard Deviation 5 |
| 2.0 mg of DE-122 | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | 1.0 ETDRS letters | Standard Deviation 7.9 |
| 4.0 mg of DE-122 | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90. | 3.3 ETDRS letters | Standard Deviation 4.5 |
Secondary
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Time frame: Baseline (Day1) and Day 90.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5 mg of DE-122 | Change From Baseline in Central Subfield Thickness (CST) at Day 90. | -116.3 microns | Standard Deviation 194.9 |
| 1.0 mg of DE-122 | Change From Baseline in Central Subfield Thickness (CST) at Day 90. | 62.7 microns | Standard Deviation 68.1 |
| 2.0 mg of DE-122 | Change From Baseline in Central Subfield Thickness (CST) at Day 90. | -36.0 microns | Standard Deviation 42.6 |
| 4.0 mg of DE-122 | Change From Baseline in Central Subfield Thickness (CST) at Day 90. | -111.3 microns | Standard Deviation 171.2 |