RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration

NCT03633084 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RBM-007-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability

  Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.

  Day 56

• Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability

  Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.

  Day 56

Secondary Outcomes (1)

• Ocular Tolerability as Assessed by Number and Nature of Adverse Events

  Day 56

Study Arms (3)

RBM-007 Injectable Solution - 0.2 mg

EXPERIMENTAL

No additional information.

Drug: RBM-007 Injectable Solution

RBM-007 Injectable Solution - 1.0 mg

EXPERIMENTAL

No additional information.

Drug: RBM-007 Injectable Solution

RBM-007 Injectable Solution - 2.0 mg

EXPERIMENTAL

No additional information.

Drug: RBM-007 Injectable Solution

Interventions

RBM-007 Injectable Solution DRUG

(No additional description)

RBM-007 Injectable Solution - 0.2 mg; RBM-007 Injectable Solution - 1.0 mg; RBM-007 Injectable Solution - 2.0 mg

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 55 years of age or older on the date of signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
• Must have had prior treatment in the study eye with any intravitreal vasoactive endothelial growth factor (VEGF) medication (at least 3 anti-VEGF) treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage.
• Best corrected visual acuity of 65 to 20 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (20/50 to 20/400) in the study eye.
• Presence of significant subretinal fluid and/or cystoid macular edema secondary to exudative age-related macular degeneration as assessed by optical coherence tomography in the study eye, with a minimum of 300 µm within the central subfield.
• Total lesion size of ≤9 disc areas, lesion containing ≤50% hemorrhage and ≤50% subretinal fibrosis and ≤50% retinal pigment epithelial atrophy in the study eye.
• Reasonably clear media and reasonable fixation ability in the study eye to allow for good quality tomography and fundus photography.
• Best Corrected Visual Acuity (BCVA) of 65 to 20 ETDRS letters (20/50 to 20/400) in the study eye.
• Presence of significant subretinal and/or intraretinal fluid secondary to exudative age-related macular degeneration as assessed by SD-OCT in the study eye, with a minimum of 300 µm within the central subfield.
• Total lesion size of ≤9 disc areas, containing ≤ 50% hemorrhage and ≤ 50% fibrosis and ≤ 50% retinal pigment epithelial atrophy in the study eye.

You may not qualify if:

• BCVA better than 65 ETDRS letters (20/50) in the study eye.
• BCVA worse than 20 ETDRS letters (20/400) in study eye.
• Fellow eye BCVA worse than 35 ETDRS letters (20/200).
• Use of any of the following treatments to the study eye:
• Intravitreal anti-VEGF injection (ranibizumab, aflibercept or bevacizumab) in the study eye within the past 4 weeks or less prior to Baseline Visit and RBM-007 injection.
• Intravitreal or periocular corticosteroid, within 3 months prior to Baseline Visit (Day 0) and throughout the study;
• Fluocinolone acetonide intravitreal implant, within 12 months prior to Baseline Visit (Day 0) and throughout the study;
• Visudyne® (verteporfin) photodynamic therapy, within 3 months prior to Baseline Visit (Day 0) and throughout the study.
• Uncontrolled or advanced glaucoma, defined by an intraocular pressure (IOP) of \>21 mmHg or cup/disc ratio \> 0.8 while on medical therapy, or chronic ocular hypotony (\<6 mmHg) in the study eye.
• Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g., active diabetic retinopathy, posterior uveitis, adult vitelliform dystrophy, moderate/severe myopic degeneration).
• History of vitrectomy surgery in the study eye.
• Anticipated need for any ocular surgery involving the study eye during the course of the study.
• Nd:YAG laser capsulotomy within 28 days prior to Baseline Visit (Day 0) in the study eye.
• Intraocular surgery, including lens removal or ophthalmologic laser procedure, within 90 days prior to Baseline Visit (Day 0) in the study eye.
• Ocular or periocular infection in either eye.

Sponsors & Collaborators

• Ribomic USA Inc: lead

Study Sites (4)

Retinal Consultants Medical Group

Sacramento, California, 95819, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95841, United States

Location

Stanford University

Stanford, California, 94303, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94704, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Yusuf Ali, Ph.D.
• Organization: Ribomic USA

yusuf.ali@ribomic.com

(707) 287-4313

Study Officials

• Yusuf Ali, Ph.D.

  Ribomic USA Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label, non-controlled, sequential, dose-escalating study

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 16, 2018
• Study Start: August 29, 2018
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Locations

US (4)