Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Ozurdex Implant
: 1. 0.7 mg DEX implant and Ranibizumab IVT injections at baseline and then PRN basis.
and:
2. 0.5 mg Ranibizumab IVT injections at baseline and then PRN basis.
C
Sponsors
LV Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with treatment naïve PCV with Center-involved macular edema or sub-retinal fluid or PED. 2 .Adults >= 40 years 3. ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye 4. 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 5. Willing, committed, and able to return for all clinic visits and complete all study- related procedures. 6. 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. 2. Sub-foveal scar 3. Decrease in visual acuity due to causes other than PCV. 4. Only one functional eye even if that eye is otherwise eligible for the study 5. 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 6. Previous use of intraocular or periocular corticosteroids in the fellow eye within the 3 months prior to Day 1 7. Previous treatment with anti-angiogenic drugs in the study eye 8. Previous treatment with anti-angiogenic drugs in the fellow eye within the 3 months prior to Day one 9. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye 10. Vitreomacular traction or epiretinal membrane in either the study eye or fellow eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision 11. Ocular inflammation or external ocular inflammation in the study eye 12. History of idiopathic or autoimmune uveitis in either eye 13. Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period 14. Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 3 months prior to Day 1 15. Aphakia or absence of the posterior capsule in the study eye 16. Uncontrolled glaucoma, defined as IOP >= 25mmHg on optimal medical regimen, in either the study eye or fellow eye or previous filtration surgery in either the study eye or fellow eye 17. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection 18. Any ocular disorders in the study eye that, in the opinion of the Investigator, may confound interpretation of study results 19. Uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen 20. Uncontrolled diabetes mellitus 21. History of cerebral vascular accident or myocardial infarction within 6 months prior to Day 1 22. Renal failure requiring dialysis or renal transplant 23. Participation in an investigational study within 30 days prior to initial screening visit that involved treatment with any drug (excluding vitamins and minerals) or device 24. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk from treatment complications 25. Pregnancy or lactation 26. History of allergy to fluorescein used in fluorescein angiography 27. History of allergy to povidone iodine 28. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed by the site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean gain in visual acuity from baseline to month 12Timepoint: Mean gain in visual acuity from baseline to month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients gaining 15 letters or more. 2. Change from baseline in central retinal thickness, assessed by OCT, at month 12. 3. To assess the polyp closure rate in subjects with PCV at the end of month 12. 4. To assess the mean number of injections of RBZ and DEX at the end of month 12. 5. Longest treatment free interval Timepoint: Every 4 weeks until month 12. | — |
Countries
India
Contacts
Public ContactDrRaja Narayanan
L V Prasad Eye Institute
Outcome results
None listed