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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - 99
Updated:10/26/2018
Start Date:August 29, 2018
End Date:August 15, 2019
Contact:Yusuf Ali, PhD
Email:yusuf.ali@ribomic.com
Phone:(707) 287 4313

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Phase 1/2 Open Label, Dose-escalation Study of the Safety and OcUlar Tolerability of a Single Intravitreal Injection of RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (SUSHI)

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.

Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt.
injection of RBM-007 in the study eye. Subjects will be followed through Day 56.

Inclusion Criteria:

1. 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.

2. At Screening Visit, subjects must meet all the following inclusion criteria:

3. 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.

4. 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.

5. 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.

6. 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.

7. 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:

8. Best Corrected Visual Acuity (BCVA) of 65 to 20 ETDRS letters (20/50 to 20/400) in the
study eye.

9. 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.

10. Total lesion size of ≤9 disc areas, containing ≤ 50% hemorrhage and ≤ 50% fibrosis and
≤ 50% retinal pigment epithelial atrophy in the study eye.

Exclusion Criteria:

Ocular exclusion criteria:

1. BCVA better than 65 ETDRS letters (20/50) in the study eye.

2. BCVA worse than 20 ETDRS letters (20/400) in study eye.

3. Fellow eye BCVA worse than 35 ETDRS letters (20/200).

Use of any of the following treatments to the study eye:

4. 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.

5. Intravitreal or periocular corticosteroid, within 3 months prior to Baseline Visit
(Day 0) and throughout the study;

6. Fluocinolone acetonide intravitreal implant, within 12 months prior to Baseline Visit
(Day 0) and throughout the study;

7. Visudyne® (verteporfin) photodynamic therapy, within 3 months prior to Baseline Visit
(Day 0) and throughout the study.

8. 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.

9. 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).

10. History of vitrectomy surgery in the study eye.

11. Anticipated need for any ocular surgery involving the study eye during the course of
the study.

12. Nd:YAG laser capsulotomy within 28 days prior to Baseline Visit (Day 0) in the study
eye.

13. Intraocular surgery, including lens removal or ophthalmologic laser procedure, within
90 days prior to Baseline Visit (Day 0) in the study eye.

14. Ocular or periocular infection in either eye.

15. Pupillary dilation inadequate for good quality fundus photography in the study eye.

16. Media opacity that would limit clinical visualization, fundus photography, fluorescein
angiography, or SD-OCT evaluation in the study eye.

17. History of herpetic ophthalmic infection in the study eye or adnexa.

18. Presence of known toxoplasmosis or toxoplasmosis scar in either eye.

19. Presence or history of any form of ocular malignancy including choroidal melanoma in
the study eye.
We found this trial at
3
sites
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-724-7752
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Sacramento, California 95819
Principal Investigator: Margaret Chang, MD
Phone: 916-339-2693
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Walnut Creek, California 94598
Principal Investigator: Subhransu Ray, MD
Phone: 925-943-6800
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Walnut Creek, CA
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