PMID- 33036583 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20220531 IS - 1471-2415 (Electronic) IS - 1471-2415 (Linking) VI - 20 IP - 1 DP - 2020 Oct 9 TI - Postmarketing safety surveillance of dexamethasone intravitreal implant in the treatment of visual impairment due to diabetic macular edema in India. PG - 405 LID - 10.1186/s12886-020-01630-7 [doi] LID - 405 AB - BACKGROUND: Diabetic macular edema (DME) is the most common cause of vision loss in diabetic patients. As India has the second largest population of diabetic patients worldwide, availability of various treatment options for DME is essential. This postmarketing surveillance study was conducted to fulfill a commitment to the Regulatory Authority of India to examine the safety of dexamethasone intravitreal (DEX) implant over 1 year in Indian patients with DME receiving >/=1 DEX implant for DME-related visual impairment in clinical practice. METHODS: This observational, prospective, non-interventional study enrolled patients aged >/=18 years scheduled to receive DEX implant for DME-related visual impairment. Baseline demographics, medical history, date of last DEX implant injection, detailed information about adverse events (AEs), AEs of special interest (AESIs), serious AEs (SAEs), and adverse drug reactions (ADRs) reported during postinjection visits and investigator telephone calls were collected. Primary outcome measures were treatment-emergent AE (TEAE), AESI, SAE, and ADR occurrences. RESULTS: Of the enrolled patients (19 sites throughout India; n = 250), 84 had received DEX implant previously; mean (standard deviation; SD) duration between prior and study entry dose was 199.4 (156.0) days, and 91 (36.4%) had >/=1 prior ophthalmic condition. Over a mean of 182.6 (88.6) follow-up days (min-max: 0-364 days), 22 TEAEs were reported by 7 (2.8%) patients, 6 of whom had previously received DEX. AESIs of increased IOP (n = 3, 6 events) and glaucoma (n = 1, 1 event) were considered non-serious, of mild/moderate severity, and related to DEX treatment. Eyelid ptosis was reported in 1 patient (1 event). Nonocular AEs included cardiac AEs (n = 3, 4 events), pyrexia (n = 1, 2 events), and dyspnea (n = 1, 2 events). Three (1.2%) patients had 12 serious AEs; most were cardiac disorders; all were unrelated to DEX treatment. Two (0.8%) deaths were considered unrelated to treatment. CONCLUSIONS: Based on voluntary reporting of adverse events in this surveillance study, DEX implant for treatment of DME-related visual impairment in the Indian population demonstrated a favorable safety profile with few treatment-related TEAEs (none were considered serious) during the 1-year follow-up. These data supplement previous findings and confirm the safety of DEX implant in this population during usual clinical practice. TRIAL REGISTRATION: World Health Organization Clinical Trials Registry: CTRI/2017/04/008396 . Registered 24 April 2017. FAU - Nair, Unnikrishnan AU - Nair U AUID- ORCID: 0000-0003-0894-5124 AD - Chaithanya Eye Hospital & Research Institute, Trivandrum, Kerala, 695004, India. dr.unninair@gmail.com. FAU - Gupta, Vishali AU - Gupta V AD - Postgraduate Institute of Medical Education & Research, Advanced Eye Center, Chandigarh, India. FAU - Sharma, Mohita AU - Sharma M AD - Tirupati Eye Centre, Noida, Gautam Budh Nagar, Uttar Pradesh, India. FAU - Joshi, Shrinivas AU - Joshi S AD - M.M. Joshi Eye Institute, Hosur Hubli, Karnataka, India. FAU - Sudhalkar, Aditya AU - Sudhalkar A AD - Raghudeep Eye Hospital, Ahmedabad, Gujarat, India. FAU - Altangerel, Undraa AU - Altangerel U AD - Global Patient Safety and Epidemiology (GPSE), Allergan, an AbbVie Company, Irvine, CA, USA. FAU - Bai, Yan AU - Bai Y AD - Global Patient Safety and Epidemiology (GPSE), Allergan, an AbbVie Company, Irvine, CA, USA. CN - India Ozurdex Postmarketing Surveillance Study Group LA - eng GR - Not applicable/Allergan (prior to acquisition by AbbVie)/ PT - Journal Article PT - Observational Study DEP - 20201009 PL - England TA - BMC Ophthalmol JT - BMC ophthalmology JID - 100967802 RN - 0 (Drug Implants) RN - 0 (Glucocorticoids) RN - 7S5I7G3JQL (Dexamethasone) SB - IM MH - Adolescent MH - Adult MH - Dexamethasone/adverse effects MH - *Diabetes Mellitus MH - *Diabetic Retinopathy/complications/drug therapy MH - Drug Implants MH - Glucocorticoids/adverse effects MH - Humans MH - India/epidemiology MH - Intravitreal Injections MH - *Macular Edema/drug therapy MH - Prospective Studies MH - Treatment Outcome MH - Visual Acuity PMC - PMC7545916 OTO - NOTNLM OT - Corticosteroid OT - Dexamethasone OT - Diabetic macular edema OT - Postmarketing OT - Safety profile COIS- Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. Unnikrishnan Nair declares no competing interests. Vishali Gupta declares no competing interests. Mohita Sharma declares no competing interests. Shrinivas Joshi declares no competing interests. Aditya Sudhalkar declares no competing interests. Undraa Altangerel is an employee of AbbVie Inc. Yan Bai was an employee of Allergan plc during the conduct of the study. FIR - Agarwal, Manisha IR - Agarwal M FIR - Balakrishnan, Divya IR - Balakrishnan D FIR - Banker, Alay IR - Banker A FIR - Borse, Nishikant IR - Borse N FIR - Gupta, Vishali IR - Gupta V FIR - Joshi, Shrinivas IR - Joshi S FIR - Khatri, Manoj IR - Khatri M FIR - Myneni, Jyotsna IR - Myneni J FIR - Nagpal, Manish IR - Nagpal M FIR - Nair, Unnikrishnan IR - Nair U FIR - Rajesh, R IR - Rajesh R FIR - Raval, Vishal R IR - Raval VR FIR - Reddy, Rajarami IR - Reddy R FIR - Salhotra, Sudhir IR - Salhotra S FIR - Saswade, Manoj IR - Saswade M FIR - Sharma, Mohita IR - Sharma M FIR - Singh, Indu IR - Singh I FIR - Sinha, Anshuman IR - Sinha A FIR - Sudhalkar, Aditya IR - Sudhalkar A EDAT- 2020/10/11 06:00 MHDA- 2021/05/15 06:00 PMCR- 2020/10/09 CRDT- 2020/10/10 05:23 PHST- 2019/07/16 00:00 [received] PHST- 2020/08/31 00:00 [accepted] PHST- 2020/10/10 05:23 [entrez] PHST- 2020/10/11 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/10/09 00:00 [pmc-release] AID - 10.1186/s12886-020-01630-7 [pii] AID - 1630 [pii] AID - 10.1186/s12886-020-01630-7 [doi] PST - epublish SO - BMC Ophthalmol. 2020 Oct 9;20(1):405. doi: 10.1186/s12886-020-01630-7.