Health Condition 1: - Health Condition 2: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Intravitreal Dexamethasone implant 0.7 mg injection at baseline visit followed by intravitreal Ranibizumab o.5 mg injection at 4 th and 5 th month from baseline visit: At the baseline s
Sponsors
Chaithanya Eye Hospital and research institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female Patients at least 18 years of age attending the outpatient clinic with NPDR and Diabetic macular edema in at least one eye during the study period will be randomly included after taking an informed consent. 2. Snellen Visual acuity (BCVA greater than 34 and lesser than 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters)
Exclusion criteria
Exclusion criteria: 1. Glycated hemoglobin (HbA1c) more than 12 at baseline. 2. Intraocular pressure (IOP) more than 22 mmHg at screening or on day 1 3. A diagnosis of glaucoma or patients with glaucoma suspects 4. A history of laser treatment within 3 months prior to screening 5. Use of anti-VEGF treatment within 3 months prior to screening 6. Use of intravitreal Steroids within 6 months prior to screening 7. Patients who are not willing to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of OZPRIME strategy in management of DME over a 24-week treatment period and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2mg)Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 3) To evaluate the number of injections required in eyes undergoing OZPRIME strategy and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg and Aflibercept 2mg). Timepoint: 24weeks;1) To evaluate the mean change of Best corrected Visual acuity following OZPRIME strategy and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2 mg).Timepoint: 24 weeks;2) To evaluate the change in retinal thickness in Optical Coherence Tomography (OCT) after 24 weeks following OZPRIME strategy and compare with antiVEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2 mg). Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Shinu Muralidharan T
Chaithanya Eye Hospital and research institute
Outcome results
None listed