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

NCT01330797 | Completed DMC

• 1 other identifier: GOZ-1
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-Related Macular Degeneration; Cataract

Keywords

Cataract; Intravitreal; Ranibizumab; LOCS III

Outcome Measures

Primary Outcomes (1)

• Lens Opacity Classification System (LOCS) III grades

  Evaluation of lens status are assessed according to LOCS III standards. Attributes of LOCS III; nuclear color (NC), nuclear opalescence (NO), cortical opacity (CO), and posterior subcapsular opacity (PSC) are graded for each eye. Each attribute range from 0.1 (clear) to 6.9 (most advanced) in 0.1 increments.Change from baseline in LOCS III grades at 1 month, 3 months, 6 months and at 12 months are recorded.

  Change from baseline in LOCS III grades at 12 months are recorded.

Secondary Outcomes (1)

• Best corrected visual acuity

  change from baseline in LOCS III grades at 12 months are recorded

Study Arms (1)

LOCS III

Cohort is composed of cases with a diagnosis of wet age-related macular degeneration and those that received intravitreal ranibizumab

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neovascular age-related macular degeneration cases undergoing ranibizumab treatment

You may qualify if:

• Neovascular age-related macular degeneration cases undergoing ranibizumab treatment
• Phakic patients

You may not qualify if:

• History of previous injections of a triamcinolone or anti-VEGF drug
• Individuals that had undergone cataract extraction
• Cases that had other intraocular surgery within the last 3 months
• Cases that had any laser treatment within 1 month (including YAG laser iridotomy)
• Cases that are using systemic steroids or anti-glaucomatous drops

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University School of Medicine, Department of Ophthalmology

Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (5)

• Sampat KM, Garg SJ. Complications of intravitreal injections. Curr Opin Ophthalmol. 2010 May;21(3):178-83. doi: 10.1097/ICU.0b013e328338679a.

  PMID: 20375895 BACKGROUND

• Jonas JB. Intravitreal triamcinolone acetonide: a change in a paradigm. Ophthalmic Res. 2006;38(4):218-45. doi: 10.1159/000093796. Epub 2006 Jun 6.

  PMID: 16763379 BACKGROUND

• Jonas JB, Kreissig I, Degenring RF. Cataract surgery after intravitreal injection of triamcinolone acetonide. Eye (Lond). 2004 Apr;18(4):361-4. doi: 10.1038/sj.eye.6700654.

  PMID: 15069430 BACKGROUND

• Regillo CD, Brown DM, Abraham P, Yue H, Ianchulev T, Schneider S, Shams N. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol. 2008 Feb;145(2):239-248. doi: 10.1016/j.ajo.2007.10.004.

  PMID: 18222192 BACKGROUND

• Chylack LT Jr, Gross GN, Pedinoff A; Ciclesonide Lenticular Safety Study Group. A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity. J Asthma. 2008 Dec;45(10):893-902. doi: 10.1080/02770900802353636.

  PMID: 19085579 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Cataract

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Study Officials

• Mehmet Baykara, M.D

  Uludag University School of Medicine, Department Of Ophthalmlogy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 7, 2011
• Study Start: January 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 7, 2011

Record last verified: 2011-01

Locations

TU (1)