Age Related Macular Degeneration
Conditions
Brief summary
This study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.
Interventions
Sterile solution
Sponsors
Maturi, Raj K., M.D., P.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects receive the study treatment
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
• General Inclusion Criteria: 1. Male or female patients, 50 years of age or older at baseline 2. Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits. • Ocular Inclusion Criteria: 3. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye 4. Presence of choroidal neovascularization secondary to AMD 5. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.
Exclusion criteria
• General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Edema | 3 months | Central subfield thickness on optical coherence tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 3 Months | Change from Baseline in Best Corrected Visual Acuity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RBM-007 Injectable Solution - 2.0 mg Single intravitreal injection in study eye
RBM-007 Injectable Solution: Sterile solution | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | RBM-007 Injectable Solution - 2.0 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Central subfield thickness | 422.8 Microns |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
| Visual Acuity | 66.6 Letters seen on eye chart |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Macular Edema
Central subfield thickness on optical coherence tomography
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RBM-007 Injectable Solution - 2.0 mg | Macular Edema | 416 Microns |
Secondary
Visual Acuity
Change from Baseline in Best Corrected Visual Acuity
Time frame: 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RBM-007 Injectable Solution - 2.0 mg | Visual Acuity | 60 Letters seen on eye chart |