Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2022
INTERVENTION: Intravitreal Bevacizumab and Topical Diclofenac Combined Therapy Group, receiving 1,25 mg/0,05 ml intravitreal Bevacizumab (Avastin®; Genentech, Inc., South San Francisco, CA, USA) administered once only using 27‐gauge needle through the superotemporal quadrant and then followed by administration of 1 mg/ml Diclofenac eyedrops (Noncort®; Cendo, Bandung, Indonesia) every 8 hours for a total 4 weeks; Intravitreal Ketorolac group, receiving 3000µg/0,1ml ketorolac once only (Rativol®; Sanbe Farma, Bandung, Indonesia) and then followed by administration of placebo eye drops (Sodium Chloride and Potassium Chloride), eyedrops administered every 8 hours for a total 4 weeks; Intravitreal Bevacizumab group receiving 1,25 mg/0,05 ml intravitreal Bevacizumab (Avastin®; Genentech, Inc., South San Francisco, CA, USA) administered once only using 27‐gauge needle through the superotemporal quadrant and then followed by administration of placebo eye drops (Sodium Chloride and Potassium Chloride), eyedrops administered every 8 hours for a total 4 weeks. For all treatment arms, the intervention will be delivered only to one eye. Adherence/fidelity of the intervention are monitored through: hospital record during intravitreal injection which is performed by vitreoretinal surgeon, during intravitreal injection the patients do not know the injected drugs; periodic phonecall/message reminder from the assistant regarding topical diclofenac or topical placebo eyedrops administration. CONDITION: diabetic macular edema;diabetes mellitus; ; diabetic macular edema ; diabetes mellitus Eye ‐ Diseases / disorders of the eye Metabolic and Endocrine ‐ Diabetes PRIMARY OUTCOME: Central Macular Thickness will be measured using Optical Coherence Tomography; [Injection Day (before administration of the intervention): (central macular thickness).; Day 28 post injection (primary endpoint: central macular thickness).] National Eye Institute Visual Function Questionnaire (NEI VFQ) 25 Composite and Subscale Score [Injection Day (before administration of the intervention): (NEI VFQ); Day 28 post injection (primary endpoint: NEI VFQ); ] Vascular endothelial growth factor (VEGF) level of tear samples ; [Injection Day (before administration of the intervention): (Vascular endothelial growth factor (VEGF) level of tear samples).; Day 28 post injection (primary endpoint: Vascular endothelial growth factor (VEGF) level of tear samples)] SECONDARY OUTCOME: Best‐Corrected Visual Acuity (BCVA) measured by Snellen chart recorded in logarithm of the minimum angle of resolution (logMAR) scale.[Injection Day (before administration of the intervention), Day 28 post injection.] INCLUSION CRITERIA: Patients diagnosed with diabetic macular edema in type 2 diabetes mellitus, over 18 years of age at the time of intravitreal injection and never received anti‐VEGF intravitreal injection therapy nor retinal laser therapy.
Epistemonikos ID: d0fd971679b3671b45cdc43fe0869cc693660f6d
First added on: Aug 25, 2024