None listed
Conditions
Brief summary
This study aim to assess the efficacy of NSAIDs in diabetic macular edema treatment regimens as primary therapy or as a complementary therapy. VEGF is a potent vasopermeability factor that has been targeted extensively in diabetic macular edema. We hypothesize that the administration of NSAID will decrease VEGF level in patients with diabetic macular edema. Included eyes underwent a full ophthalmologic examination, spectoral-domain optical coherence tomography and tear sample collection at baseline. Eyes were randomly assigned to one of the three groups, intravitreal Bevacizumab and topical Diclofenac, intravitreal Ketorolac, intravitreal Bevacizumab. The eyes received single intravitreal injection throughout the study period. Patients were given questionnaire NEI VFQ25. The follow up consist of complete ophthalmologic examination and questionnaire at day 7 and day 28 after intravitreal injection. Best-corrected VA measured by Snellen chart was recorded in logarithm of the minimum angle of resolution (logMAR) scale. OCT and tear sample collection was repeated at day 28. VEGF level of tear samples was measured using ELISA Kit.
Interventions
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, B
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.
Sponsors
Supanji Haryanto
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Patients who have significant media opacities that could preclude macular ocular coherence tomography (OCT) examination, failed to receive intravitreal injection of Bevacizumab for any reason, underwent intraocular surgery during the study period, were having infection / inflammation in the anterior segment and those who were on systemic or topical corticosteroid / Non Steroid Anti Inflammation Drugs (NSAID) therapy.
Outcome results
None listed