Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Aflibercept: Participants will receive one aflibercept injection (2 mg
equivalent to 50 μL solution for
injection) per month (every four weeks) for five consecutive doses, followed by one injection every alternate month (every 8 weeks) for rest of the duration.
Control
Sponsors
Bayer Zydus Pharma Private Limited
Bayer AG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male adult participant >=18 years of age, with type 1 or 2 diabetes mellitus. 2. Participant must have DME secondary to diabetes mellitus, involving the centre of the macula (defined as the area of the centre subfield of OCT) in the study eye. 3. Decrease in vision, determined to be primarily the result of DME in the study eye. 4. Retinal thickness of >=300 µm in the study eye, as assessed by OCT. 5. BCVA ETDRS letter score of 73 to 24 (i.e., VA of 20/50 to 20/320) or equivalent in the study eye. 6. Participant for whom the decision to initiate treatment with IVT aflibercept has been made by the treating Investigator/Physician. 7. Willing and able to comply with clinic visits and study-related procedures. 8. Provide a signed ICF prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1. Having any contraindications to the use of IVT aflibercept as listed in the local prescribing information (i.e., ocular or periocular infection, active severe intraocular inflammation, and known hypersensitivity to aflibercept or to any of the excipients). 2. History of vitreoretinal surgery and/or scleral buckling in the study eye. 3. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye. 4. Known history of allergy to fluorescein used in fluorescein angiography, and indocyanine green used in indocyanine green angiography. As indocyanine green dye contains iodine, so severe allergic reactions are possible in patients allergic to iodine. 5. Any laser photocoagulation (panretinal or macular) in the study eye within the last 3 months of Day 1. 6. Any cataract surgery in the study eye within the last 3 months of Day 1. 7. Any intraocular surgery in the study eye within the last 3 months of Day 1. 8. Received previous/ prior treatment as mentioned below: a) Received anti-VEGF drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc., including aflibercept) within the last 3 months of Day 1. b) Received IVT dexamethasone or triamcinolone in the study eye within the last 3 months of Day 1. c) Received intraocular or periocular corticosteroids in the study eye within the last 4 months of Day 1. d) Had fluocinolone implant in the study eye within the last 3 years of Day 1. e) Had dexamethasone implant in the study eye within the last 6 months of Day 1. f) systemic anti-angiogenic agents within 6 months of Day 1. 9. Uncontrolled glaucoma in the study eye (patient who has had filtration surgery in the past, or likely to need filtration surgery in the future). 10. IOP >=25 mm Hg in the study eye. 11. Only 1 functional eye even if that eye is otherwise eligible for the study. 12. Ocular media of insufficient quality to obtain fundus and OCT images. 13. Uncontrolled DM in the opinion of the investigator. 14. Uncontrolled blood pressure (BP) (defined as systolic >160 mm Hg or diastolic >95 mm Hg while patient is sitting). 15. History of cerebrovascular accident or MI within 6 months of Day 1. 16. Renal failure, dialysis, or history of renal transplant. 17. Participated in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device. 18. Pregnant or breast-feeding women. 19. Sexually active men or WOCBPa who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or jelly). 20. WOCBPa with either a positive pregnancy test result or no pregnancy test at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety of IVT aflibercept for the treatment of DME in a phase IV setting. Endpoint: Frequency (number) of ocular and non ocular TEAEs. Timepoint: Throughout the study conduct. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the efficacy of use of IVT aflibercept for the treatment of DME in a phase IV setting. Endpoint: 1. The change in BCVA from baseline to week 52, as assessed using the ETDRS chart or equivalent. 2. Change in CRT from baseline to week 52 asmeasured by OCT, FA. 3. Proportion of eyes that gain â?¥ 5, 10 and 15 ETDRS letters from baseline to Week 52. 4. Proportion of eyes with a â?¥2 step improvement in the ETDRS DRSS score.Timepoint: From baseline to Week 52. | — |
Countries
India
Contacts
Public ContactDr Smruti Jagtap
Bayer Zydus Pharma Ltd.
Outcome results
None listed