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

Completed · Phase 1/Phase 2

Conditions studied: Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03633084

Run by

Ribomic USA Inc

People needed

9

Starts

2018-08-29

Expected to finish

2019-06-26

Last updated by the study team

2021-01-05

Who can join

Age: 55 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.
• At Screening Visit, subjects must meet all the following inclusion criteria:
• 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.
• At Baseline Visit (Day 0), subjects must meet all the following inclusion criteria:
• 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…

• Ocular exclusion criteria:
• 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.
• Pupillary dilation inadequate for good quality fundus photography in the study eye.
• Media opacity that would limit clinical visualization, fundus photography, fluorescein angiography, or SD-OCT evaluation in the study eye.
• History of herpetic ophthalmic infection in the study eye or adnexa.
• Presence of known toxoplasmosis or toxoplasmosis scar in either eye.
• Presence or history of any form of ocular malignancy including choroidal melanoma in the study eye.

Where it is running

• Retinal Consultants Medical Group — Sacramento, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Stanford University — Stanford, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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