Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Intervention1: Intravitreal injection of Brolucizumab: Follow up every 4 weeks until month 12.
Control Intervention1: NA: NA
Sponsors
L V Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Eyes with recalcitrant diabetic macular edema (recalcitrant edema is defined as persisting macular edema (less than 50 microns decrease) after two consecutive anti-VEGF injections with mean retinal thickness of more than 250 μm in the central subfield on OCT 2.Availability of baseline OCT and clinical findings at the time of presentation 3.Adults >= 18 years 4.ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye 5.Men and women of childbearing potential must be willing to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant during the full course of the study 6.Willing, committed, and able to return for ALL clinic visits and complete all study- related procedures 7.Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. History of vitreoretinal surgery in the study eye or anticipated within the next 12 months following Day 1 2. Prior episode of intraocular inflammation 3. Decrease in visual acuity due to causes other than DME 4. Only one functional eye even if that eye is otherwise eligible for the study 5. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye 6. History or presence of AMD (dry or wet form) that is considered by the investigator to significantly affect central vision, 7. Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1 8. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye 8. History of idiopathic or autoimmune uveitis in either eye 9. Structural damage to the center of the macula in either the study eye or fellow eye that is likely to preclude improvement in VA following the resolution of macular edema 10. Spherical equivalent of the refractive error in the study eye of more than - 8 diopters myopia (for subjects who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than - 8 diopters myopia) 11. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection 12. Any ocular disorders in the study eye that, in the opinion of the Investigator, may confound interpretation of study results 13. Pregnancy or lactation 14. History of allergy to fluorescein used in fluorescein angiography 15. History of allergy to povidone iodine 16. Inability to obtain fundus photographs , fluorescein angiograms and OCT of sufficient quality to be analyzed by the site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who gain at least 15 letters in BCVA at Week 24 Time point compared to baseline Timepoint: Every 4 weeks until month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in BCVA score at Week 24 2. Change from baseline in central retinal thickness, assessed by OCT, at Week 24 3. Proportion of subjects developing any adverse event including intraocular inflammation or vasculitis Timepoint: Every 4 weeks until month 12 | — |
Countries
India
Contacts
Public ContactDrMudit Tyagi
L V Prasad Eye Institute
Outcome results
None listed