AAVCAGsCD59 for the Treatment of Wet AMD

• Status: Active, not recruiting
• Trial end date: 2022-01-29
• Target enrollment: 0
• Participant gender: All

Summary

Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central subfoveal thickness (CST) of >50 micrometers on OCT from Day 0, new subretinal hemorrhage on clinical exam, and/or loss of 10 or more ETDRS letters from the previous month exam.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hemera Biosciences; Janssen Research & Development, LLC
• Treatments: Aflibercept; Bevacizumab; Prednisolone; Ranibizumab

Criteria

Inclusion Criteria:

1. Men or women 50 years of age or older.

2. Treatment naive Wet AMD with no evidence of subretinal fibrosis under the fovea.

3. Presence of intraretinal and/or subretinal fluid on OCT.

4. Best corrected visual acuity (BCVA) Snellen equivalent 20/25 to 20/400 in the study eye using ETDRS charts at a starting distance of 4m.

5. Adequate pupillary dilation to permit ocular examination and testing.

6. Ability and willingness to return for all scheduled visits and assessments.

7. Understand and comply with the clinical protocol and provide written informed consent prior to any study-related procedure.

8. All fertile men must be willing to use barrier contraception during the study.

9. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception for the duration of the trial. A woman of childbearing potential is defined as any female who has had menses within the last two years or has not undergone a hysterectomy or surgical sterilization.

Exclusion Criteria:

1. Wet AMD secondary to non-AMD etiologies.

2. Subretinal hemorrhage that interferes with the ability to adequately measure visual acuity or follow retinal or subretinal fluid collection on OCT.

3. Serous pigment epithelial detachment (PED) that is >50% of the CNV lesion, >400µm in any diameter, or presence of a RPE tear.

4. Presence of polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous retinopathy, or symptomatic vitreomacular adhesion.

5. Previous macular laser photocoagulation for CNV, photodynamic therapy (PDT), ocular radiation, or subretinal surgery for CNV in the study eye.

6. History of conditions in the study eye which might alter visual acuity or interfere with study testing including clinically significant macular edema, central retinal vein occlusion, macular branch retinal vein occlusion, and optic neuropathy.

7. Active uncontrolled glaucoma with IOP>30 mmHg despite treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, and optic atrophy from glaucoma.

8. Likely candidate for intraocular surgery (including cataract surgery) in the study eye during the clinical trial.

9. Acute or chronic infection in the study eye.

10. History of uveitis unrelated to eye surgery in the study eye or opposite eye requiring treatment with topical corticosteroids or systemic immunosuppression within 24 months of enrollment.

11. Any contraindication to intravitreal injection.

12. Use intravitreal (study eye) corticosteroids within 3 months prior to screening.

13. Any of the following underlying systemic diseases:

• Unstable or severe cardiovascular disease, e.g., congestive heart failure (New York Heart Association Functional class III or IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia;

• Cerebrovascular disease within 12 months prior to Screening that impairs the patient's ability to participate in the clinical trial;

• Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease) of a level that prevents adequate evaluation of the subject during the study;

• Has an active malignancy or is currently undergoing treatment for an active malignancy at Screening, or has a history of malignancy that precludes completion of this 12-month study;

• Immunocompromised conditions and/or need for immunosuppressive therapy

14. Any significant poorly controlled illness that would preclude study compliance and follow-up

15. Current or prior use of any medication known to be toxic to the retina or optic nerve including, but not limited, to chloroquine/hydrochloroquine, deferoxamine, phenothiazines and ethambutol

16. Previous treatment with any ocular or systemic gene transfer product

17. Received any investigational product within 120 days prior to screening

18. Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up