Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE
IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA:
A RANDOMIZED CONTROLLED TRIAL: Group 1: Aflibercept Arm
Intravitreal Aflib
Sponsors
COMMAND HOSPITAL EASTERN COMMAND KOLKATA
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria- Male and female patients more than 18 years old with visual impairment due to naive-DME. Patients with type 1 or type 2 diabetes mellitus and HbA1c of less than 10 percentage at screening Baseline CST more than 300 m on spectral-domain OCT. BCVA between 20/40(6/12) and 20/320(6/96) (ETDRS letters 70 to 25). Hemoglobin A1c less than 10 percentage Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients with HbA1C more than 10 mg percentage or those who did not have stable control of diabetes since the last 3 months. Patients with a history of vitrectomy, cataract leading to poor imaging, intra-ocular surgery within 3 months of enrollment into the study, aphakia, epiretinal membrane, vitreomacular traction. Patient with uncontrolled hypertension (defined as a systolic blood pressure more than 160 mm Hg or a diastolic blood pressure more than 95 mm Hg) Patient with history of cerebrovascular accident or myocardial infarction within 6 months, renal failure requiring dialysis or renal transplant, or other retinal vascular diseases Patient with existing or suspected ocular or periocular infection in the study eye. Patient with an existing intraocular inflammation (IOI). Patient with uncontrolled glaucoma (defined as intraocular pressure more than 25 mmHg despite treatment with anti-glaucoma medication,) or according to Investigator s judgment. Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye Use of dexamethasone intravitreal implant (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time. Laser photocoagulation (focal/grid or pan retinal) in the study eye during the 3-month period prior to baseline Intraocular surgery including YAG laser in the study eye during the 3-month period prior to baseline Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG pregnancy test Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques Proliferative diabetic retinopathy requiring Pan retinal photocoagulation (PRP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of intravitreal Aflibercept and intravitreal Dexamethasone implant in improving best-corrected visual acuity (BCVA) in treatment-naive DME patientsTimepoint: Post Operative day-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH | — |
Secondary
| Measure | Time frame |
|---|---|
| a)Safety profile (adverse events, intraocular pressure rise, cataract progression). b)Rescue therapy response rate in non-responders. c)Change in central macular thickness (CMT) on OCT. d)Need for additional interventions (repeat dexamethasone, additional anti-VEG, laser) Timepoint: POD-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH | — |
Countries
India
Contacts
Public ContactDR KAUSHALENDRA SINGH
COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA
Outcome results
None listed