Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Intervention1: COVENTIONAL INTRAVITREAL ANTI VEGF AGENTS: Intravitreal injection of Anti - VEGF agents like RANIBIZUMAB/ AVASTIN/ AFLIBERCEPT will be done in eyes having diabetic macular edema for m
Sponsors
Dr Nafeezathul Miziriya H
Dr RAJKUMAR MAHESHWARI
Dr SAJEEV CHERIAN JACOB
Dr SAURAV MAHAJAN
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Diabetic Macular Edema (DME): Confirmed by clinical examination and optical coherence tomography (OCT). 2. Previous Anti-VEGF Therapy: Patients who have received prior treatment with conventional anti-VEGF agents such as ranibizumab, aflibercept, or bevacizumab. 3. Indication for Brolucizumab Therapy: Senior retina specialist to decide for eyes of patients requiring a switch to brolucizumab due to suboptimal response, recurrence, or tolerance issues with previous anti-VEGF therapy(refractory DME). 4. Age: Adults aged 18 years and older. 5. Ability to Provide Consent: Patients willing to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior Brolucizumab Treatment: Patients who have already received brolucizumab for same or any other ocular indication. 2. Recent Intraocular Surgery: Any ocular surgery, including cataract surgery, within the last 3 months. 3. Active Ocular Infections or Inflammation: Presence of endophthalmitis, uveitis, or scleritis in the study eye. 4. Advance Proliferative Diabetic Retinopathy (PDR): Severe pathologies requiring vitrectomy eg. Macular tractional detachments 5. Significant Media Opacities: Presence of dense cataracts, vitreous hemorrhage, or other conditions affecting accurate OCT imaging. 6. Uncontrolled Intraocular Pressure (IOP): Patients with IOP more than 25 mmHg despite maximum medical treatment. 7. Pregnancy or Breastfeeding: Women who are pregnant, planning pregnancy, or currently breastfeeding. 8. Hypersensitivity to Brolucizumab or its Components: Known allergy to the drug or any of its excipients. 9. Patients not coming for follow up are considered as drop outs & will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Best Corrected Visual Acuity in LogMAR units 2. Central Macular Thickness in micrometers calculated using OCT ruler tool 3. Macular Volume in millimeter cube using OCT valuesTimepoint: We will look for these parameters at 6 different visits: 1. baseline, just before injection of Intravitreal anti - VEGF injection 2. 2 weeks after Intravitreal anti-VEGF injection 3. 6 weeks after Intravitreal anti- VEGF injection 4. before injecting Intravitreal brolucizumab injection 5. 2 weeks after Intravitreal brolucizumab injection 6. 6 weeks after Intravitreal brolucizumab injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage (%) of eyes required repeat intravitreal injection in:Timepoint: a) 6 weeks b) 10 weeks c) 14 weeks d) 18 weeks ;Number of eyes which did not require repeat intravitreal brolucizumabTimepoint: up to 18 weeks;Evaluate the occurrence of any adverse effects i) Anterior chamber cells & flare ii) Subconjunctival haemorrhage iii) Hyperaemia iv) Endophthalmitis v) Vascular occlusion vi) Vascular sheathing vii) Vitritis Timepoint: whole study period | — |
Countries
India
Contacts
Public ContactDr. Nafeezathul Miziriya H
Ahalia foudation eye hospital
Outcome results
None listed