drugset / Trial / NCT05715385
Comparison of Treatments in Diabetic Macular Edema
RandomizedParallel-groupDouble-blindTreatment
Summary
Prospective or cohort study to compare the effects of grid macular laser, topical bromfenac 0.09% and placebo (carboxymethyl cellulose 0.5%) medication in diabetic macular edema. 60 eyes with macular edema of two types i.e. cystoid macular edema (CME) and clinically significant macular edema (CSME) were divided into three groups with 20 patients in each group. One group was treated with grid laser photocoagulation, the second group was treated with topical bromfenac 0.09% drops two times a day and the third group was treated with topical carboxy methyl cellulose 0.5% three times a day (placebo treatment).
Timeline
- Start
- 2014-11
- Primary completion
- 2015-10
- Completion
- 2015-10
Publications
- Background Pinna A, Blasetti F, Ricci GD, Boscia F. Bromfenac eyedrops in the treatment of diabetic macular edema: a pilot study. Eur J Ophthalmol. 2017 May 11;27(3):326-330. doi: 10.5301/ejo.5000888. Epub 2016 Nov 16.
- Background Busch C, Fraser-Bell S, Zur D, Rodriguez-Valdes PJ, Cebeci Z, Lupidi M, Fung AT, Gabrielle PH, Giancipoli E, Chaikitmongkol V, Okada M, Lains I, Santos AR, Kunavisarut P, Sala-Puigdollers A, Chhablani J, Ozimek M, Hilely A, Unterlauft JD, Loewenstein A, Iglicki M, Rehak M; International Retina Group. Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study. Acta Diabetol. 2019 Jul;56(7):777-784. doi: 10.1007/s00592-019-01310-z. Epub 2019 Mar 22.
- Background Baklayan GA, Munoz M. The ocular distribution of (14)C-labeled bromfenac ophthalmic solution 0.07% in a rabbit model. Clin Ophthalmol. 2014 Sep 4;8:1717-24. doi: 10.2147/OPTH.S66638. eCollection 2014.
- Background Schoenberger SD, Kim SJ. Nonsteroidal anti-inflammatory drugs for retinal disease. Int J Inflam. 2013;2013:281981. doi: 10.1155/2013/281981. Epub 2013 Jan 14.
- Background Waterbury LD, Silliman D, Jolas T. Comparison of cyclooxygenase inhibitory activity and ocular anti-inflammatory effects of ketorolac tromethamine and bromfenac sodium. Curr Med Res Opin. 2006 Jun;22(6):1133-40. doi: 10.1185/030079906X112471.
- Background Ahmadi MA, Lim JI. Update on laser treatment of diabetic macular edema. Int Ophthalmol Clin. 2009 Spring;49(2):87-94. doi: 10.1097/IIO.0b013e31819fd6b2. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bromfenac | Other / unclassified | 0.09 % | Topical |