Clinical trial NCT04640272: A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
Official title: A Multi-Center, Open Label, TOFU Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age-related Macular Degeneration
Lead sponsor: Ribomic USA Inc
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, non-comparative
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
2. Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures.
3. Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
4. Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline.
5. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
6. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.
7. BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.
8. Reasonably clear media and some fixation in the study eye to allow for good quality SD-OCT and fundus photography.

Exclusion Criteria:

* 1. Subjects whose vision have improved \>15 BCVA letters at exit visit of previous study over its baseline 2. Subjects who experienced any drug related serious adverse event during previous study

Primary outcomes:
measure: Visual Acuity - Continuous
timeFrame: Month 4
Secondary outcomes:
measure: Visual Acuity - Categorical
timeFrame: Month 4
measure: Change From Baseline in Central Macular Subfield Thickness
timeFrame: Month 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Sacramento
country: United States
facility: Retinal Medical Consultants Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Indianapolis
country: United States
facility: Raj K. Maturi, M.D., P.C.
state: Indiana
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: Ribomic USA Inc
name: Padma Bezwada, PhD
role: STUDY_DIRECTOR
References: