Wet age-related macular degeneration Eye Diseases
Conditions
Interventions
U8:ranibizumab 8.5 mg/ml eye drops – a single daily dose for 12 weeks
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observations relating to local ocular tolerability, including: visual analogue scale (VAS) scores for comfort, slit lamp biomicroscopy findings (e.g., conjunctival hyperaemia, corneal changes), visual acuity and fundus ophthalmoscopy 1. A global ocular discomfort score will be determined using a 100 mm visual analogue scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. This evaluation is to be performed before any ophthalmic assessment at a given study visit 2. Specific ocular symptoms assessed at the time of the VAS including foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia 3. Slit-lamp examination to assess the eyelid margin, conjunctiva, cornea, anterior chamber, iris and lens with the instillation of fluorescein to evaluate corneal fluorescein staining (modified Oxford scale) and tear film break-up time Measured 2 weekly whilst taking the trial eye drop, starting from 1 month (30 days) following the third standard anti-VEGF injection 3 until the patient completes 4 months of the trial eye drop. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoint and outcome measures: Patterns of disease activity that may need for retreatment where the re-treatment with intravitreal ranibizumab is indicated by any new or increase in disease activity as determined by: 1. >5-letter decrease in VA compared to previous vision 2. Any evidence of disease activity on SD-OCT (e.g. intraretinal fluid, subretinal fluid, or subretinal pigment epithelial fluid) using Spectralis-OCT Safety endpoints: 1. Observations on the safety and tolerability of U8:ranibizumab 8.5 mg/ml eye drops, including ocular and non-ocular events noted during treatment and 30 days following trial discontinuation. 2. Non-ocular adverse events will be assessed for the safety set; ocular adverse events will be assessed for the primary treated eye set. 3. Safety will be assessed through AEs, and change in local ocular tolerability - assessed using a visual analogue scale (VAS), slit-lamp biomicroscopy to assess conjunctival hyperaemia and corneal toxicity, visual acuity and fundus ophthalmoscopy 4. A global ocular discomfort score will be determined using a 100 mm visual analogue scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. This evaluation is to be performed before any ophthalmic assessment at a given study visit. 5. Specific ocular symptoms to be assessed with the VAS include: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia 6. Slit-lamp examination to assess the eyelid margin, conjunctiva, cornea, anterior chamber, iris and lens with the instillation of fluorescein to evaluate corneal fluorescein staining (modified Oxford scale) and tear film break-up time. 7. Concomitant medication use will also be documented. 8. All SAEs reported to or noted by the clinician from the time the patient signs the informed consent until 30 days after study discontinuation will be recorded in the AE CRF and reported to Sponsor (please see section 9: Ph | — |
Countries
England, United Kingdom
Contacts
Public ContactFrancesca Cordeiro
Outcome results
None listed