CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01330797
NCT01330797N/ACompleted

The Effect of Ranibizumab on Eye Lens Opacity in Cases With Age-Related Macular Degeneration

Uludag University·observational·Posted Apr 7, 2011·Updated Apr 7, 2011

In Brief

An observational study for Age-Related Macular Degeneration and Cataract. Completed, enrolled 13 participants across 1 site.

Detailed Summary

Purpose To evaluate the cataractogenic effect of intravitreal ranibizumab with the use of Lens Opacity Classification System III (LOCS III). Settings Cases with a diagnosis of wet AMD were included in this university practice based prospective study. Methods All cases had monthly injections of intravitreal ranibizumab in the first 3 months; subsequently an OCT-guided pro re nata injection regimen has been adopted. All cases had a comprehensive eye examination and LOCS III evaluation at baseline and 1, 3, 6 and 12 months after the initial injection. Examination outcomes and change from baseline in LOCS III grades at 12 months were recorded. Results Eighteen eyes of 13 cases (7 female, 6 male) were included in this study. The mean age at the baseline was 75,3 + 6,6 years. A mean of 3,4 + 0,7 injections were given on each eye. Mean follow-up was 13,83 + 2,33 months. Baseline mean visual acuity improved from 1,04 + 0,10 logMAR units to 0,76 + 0,26 logMAR units after 3 injections (P \< 0.05). At the 12th month of follow-up mean visual acuity was 0,71 + 0,27 logMAR units. According to LOCS III grades none of the cases had a prominent change in nuclear color, nuclear opalescence, cortical and posterior subcapsular opacification throughout the follow-up. IOP remained stable at all follow-up points. No complications were recorded throughout the study. Conclusion Intravitreal ranibizumab is an efficient treatment in wet AMD. Results of LOCS III assessments in this pilot study suggest that intravitreal ranibizumab has no effect on the progression of lens opacity.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2011
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.2 years ago