Health Condition 1: H570- Anomalies of pupillary function
Conditions
Interventions
Intervention1: Ranibizumab: Ranibizumab with P Score
Intervention2: Ranibizumab: Assess the P Score prior Ranibizumab therapy among randomly selected 100 patients as â??Trial Groupâ?? and 100 patients
Sponsors
Regional Institute of Ophthalmology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 70 years (both inclusive). 2. Diagnosis of diabetes mellitus ( type 1 or type 2). 3. Able and willing to provide informed consent. 4. Definite retinal thicking due to diabetic macular edema based on clinical examination, OCT and DFA involving the centre of the macula. 5. Media clarity, papillary dilatation, and patient cooperation sufficient For adequate fundus photographs. 6. IOP below 21 mmhg.
Exclusion criteria
Exclusion criteria: 1. History of chronic renal failure requiring dialysis or kidney transplant. 2. Known allergy to any corticosteroid or any component of the delivery vehicle. 3. History of systemic (e.g. oral, IV, IM, epidural, bursal) corticosteroids within 4. Months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week. 5. Intraocular pressure 6. History of open angle glaucoma. 7. History of steroid-induced intraocular pressure elevation that required IOP lowering agents. 8. History of prior treatment with intravitreal corticosteroids within 6 months prior to randomization. 9. History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization. 10.History of panretinal scatter photocoagulation (PRP) within prior 4 months or anticipated within the next 6 months following randomization. 11. History of major ocular surgery ( including cataract extraction, scleral buckle, any intraocular surgery etc.) within prior 6 months or anticipated within the next 6 months following randomization. 12.History of prior herpetic ocular infection. 13. An ocular condition is present such that visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, nonretinal conditions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from baseline in the Best correcterd Visual Acuity and Central Macular Thickness.Timepoint: From baseline to week 06 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean Change from Baseline in the Best Corrected Visual Acuity Score 2.Mean Changes in Area of Fluorescein Leakage from Baseline 3.Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination 4.Plasma Concentration of VEGF-R2 5.Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline 6.Mean Changes in NEI-VFQ-25 Composite Score from BaselineTimepoint: From baseline to visit 06 | — |
Countries
India
Contacts
Public ContactDr Lakshmi Kanta Mondal
Regional Institute of Ophthalmology
Outcome results
None listed