Session Title: Quick Fire Free Paper 3
Session Date/Time: Thursday 11/09/2014 | 14:30-16:00
Paper Time: 14:45
Venue: Boulevard D
First Author: : N.Yadav INDIA
Co Author(s): : T. Sharma A. Banker A. Naik S. Sarkar
Systemic and ocular co-morbidities have damaging effects on the eyes of Neovascular age-related macular degeneration (nAMD) which is the leading cause of visual impairment in individuals older than 50 years. However, there is a paucity of data on associated co-morbidities in Indian nAMD population. Hence we present data on ocular and systemic co-morbidities in Indian nAMD patients from UNVEIL (Utilizing raNibizumab intraVitrEal Injection in a reaL-world setting) study, which will give an insight into various co-morbidities associated with nAMD.
Patients with nAMD, who were prescribed Intra vitreal Ranibizumab( IVR) by clinical judgment of the investigators, were included in this study. Study was conducted at 181 centres across India, between September 2010 to April 2013.
This was a non-interventional, multi-centre, prospective study in India, included nAMD patients treated with IVR, in adherence with the local prescribing information (PI), as per eligibility criteria. At baseline, investigators documented information on age, gender, duration of nAMD, Best-corrected visual acuity (BCVA), and ocular and systemic co-morbidities. Patients were followed up over the period of 12 months. Safety monitoring included the monitoring and reporting of all ocular and systemic adverse events (AEs) and serious adverse events (SAEs), during course of study.
A total of 650 patients were included in the study. 396 males and 254 females (M:F =3:2 ) with age (mean±SD) of 66.6±12.68 years, were enrolled in this study. 40% of the patients were ≤64 years of age. Of 650 patients, 257 (39.5%) patients had a history of neovascular AMD in left eye, 261 (40.2%) patients in right eye, and 130 (20.0%) patients in both eyes. The duration of AMD was 0.4±1.07 years (mean±SD). At baseline, mean BCVA was 68.0±20.07 and CRT was 359.5±47.67 μm. Hypertension and diabetes mellitus were the most common systemic co-morbidities, reported by, 45% and 31% patients, respectively. 6.5% of the patients had past history of cardiovascular event, 0.3% patients had history of cerebrovascular event, whereas 1% patient had dyslipidemia. Ocular co-morbidities reported included cataract in 8%, pseudo-phakia in 7.25% and myopia in 2.5%, patients. Family history of nAMD was present in 8 (1.25%) patients and 18 (2.7%) patients were smokers or past smokers.
The present study data was consistent with previous large scale epidemiological studies with respect to age and systemic co-morbidities. As per exclusion criteria IVR was not administered in patients with increase intraocular pressure. So incidence of glaucoma with nAMD couldn’t be captured. However, cataract was the main ocular diseases coexisting with nAMD in the patients studied. Previous cataract surgery may be a strong risk factor for nAMD. The present study suggests 1.5 times higher prevalence in males which has to confirmed further by large epidemiological study. In addition, significant association between presence of hypertension and diabetes with nAMD was found in present study. Therefore, the co-morbidities need to be treated early and factors predisposing to them modified so as to minimize vision loss in the patients. Significant increases in nAMD risk with smokers were seen in all the meta-analyses but in the present analysis, the numbers of smokers were less. No significant association was found between nAMD and previous cardiovascular/cerebrovascular events. The present study demonstrates that the patients with nAMD in India seek medical attention at an early stage which indicates a significant subjective vision loss even in early nAMD.