A Phase I/IIa open-label proof of concept study to assess the safety, tolerability and efficacy of U8:Ranibizumab Eye drops in patients with choroidal neovascularisation
Wet age-related macular degeneration
U8:ranibizumab 8.5 mg/ml eye drops – a single daily dose for 12 weeks
1. Aged ≥60 years at the time of signing informed consent. 2. Males and females (WONCBP*) 3. Clear optical media in the studied eye. 4. Refractive error not higher than spherical equivalent of 10 D and best corrected visual acuity equal to 6/24 or better at qualification. 5. Subjects who have capacity to consent, have personally signed and dated the informed consent form 6. Subjects who are having treatment with ranibizumab for wet AMD initiated. 7. Subjects should have shown a good response to loading doses of anti-VEGF (3 injections of anti-VEGF over 3 months) before ranibizumab eye drops are started. The good response will be as determined by the clinician. 8. Ability to administer eye drops independently or with assistance *WONCBP: not considered to be a women of childbearing potential, i.e., postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. ** Participant will be provided with necessary training tools to facilitate eye drop use, this will be through the means of visual graphics and booklets demonstrating use.
1. Subjects with “only eye” (one functional eye) 2. Presence of severe, unstable or uncontrolled systemic disease, for example, recent myocardial infarction, recent stroke 3. Body weight <40 kg or >150 kg 4. If patients are unable to self-administer, comply with the study or follow-up procedures, we will explore whether there is a carer or friend/relative who can. If there is no such person who can help instil drops, then this patient will be excluded. 5. Subjects who have had ocular surgery within the past 3 months, or planned surgery in the study eye during the course of the trial 6. Currently being treated for cancer or any other disease likely to adversely affect participation in this study 7. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab) or Human Immunodeficiency Virus (HIV) 1 and 2 antibody results, as per patients’ electronic medical records 8. History of alcoholism or drug addiction within the last 2 years, as per patients’ electronic medical records 9. History or active uveitis 10. History of systemic vasculitis or collagenosis 11. Evidence of previous retinal vascular disease, for example, retinal vein occlusion, retinal artery occlusion 12. Individuals with terminal illness, or clinically significant mental illness as judged by the investigator 13. Simultaneous participation in a study that includes administration of any investigational drug or procedure 14. Systemic or ocular treatment with any VEGF inhibitor other than ranibizumab in the 90 days prior to enrolment 15. The non-study eye has a best corrected visual acuity (BCVA) worse than 20 letters (ETDRS) at the screening visit 16. Women of childbearing potential (WOCBP) 17. If participant is unable to read and understand English language