Macular Degeneration
Conditions
Keywords
AMD, Wet AMD
Brief summary
This is a Phase II randomized, double-masked study comparing the safety and efficacy of ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with neovascular (wet) age-related macular degeneration (NV-AMD).
Interventions
DRUGMecamylamine
DRUGPlacebo
Sponsors
CoMentis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. | Baseline to Week 48 |
Countries
Brazil, Czechia, Mexico, Poland, Russia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1% Mecamylamine | 115 |
| 0.3% Mecamylamine | 114 |
| Placebo | 114 |
| Total | 343 |
Baseline characteristics
| Characteristic | 1% Mecamylamine | 0.3% Mecamylamine | Placebo | Total |
|---|---|---|---|---|
| Age Continuous | 73.2 years STANDARD_DEVIATION 8 | 72.6 years STANDARD_DEVIATION 8.7 | 71.3 years STANDARD_DEVIATION 7.7 | 72.4 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment Brazil | 15 participants | 13 participants | 16 participants | 44 participants |
| Region of Enrollment Czech Republic | 11 participants | 15 participants | 12 participants | 38 participants |
| Region of Enrollment Mexico | 7 participants | 7 participants | 6 participants | 20 participants |
| Region of Enrollment Poland | 19 participants | 21 participants | 17 participants | 57 participants |
| Region of Enrollment Russian Federation | 26 participants | 26 participants | 28 participants | 80 participants |
| Region of Enrollment Ukraine | 34 participants | 32 participants | 35 participants | 101 participants |
| Region of Enrollment United States | 3 participants | 0 participants | 0 participants | 3 participants |
| Sex: Female, Male Female | 65 Participants | 71 Participants | 77 Participants | 213 Participants |
| Sex: Female, Male Male | 50 Participants | 43 Participants | 37 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 68 / 115 | 57 / 114 | 57 / 114 |
| serious Total, serious adverse events | 8 / 115 | 8 / 115 | 7 / 114 |
Outcome results
Primary
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Time frame: Baseline to Week 48
Population: A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1% Mecamylamine | Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. | 88 Percent of subjects |
| 0.3% Mecamylamine | Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. | 86 Percent of subjects |
| Placebo | Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. | 92 Percent of subjects |
p-value: >0.05ANCOVA