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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330797
• Other study ID #: GOZ-1
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: April 6, 2011
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

In the last decade, significant progress has been made in the treatment of wet AMD. At the present intravitreal anti-VEGF therapy has become the mainstay of treatment. Nevertheless, intravitreal application is a hazardous procedure with a wide range of complications. Endophthalmitis, intraocular pressure (IOP) elevation, retinal detachment, vitreous hemorrhage, and cataract are among the major complications.

The current study is focused on the cataractogenic potential of intravitreal ranibizumab. Cataract formation following intravitreal application is frequently associated with an inadvertent trauma at the procedure. However, occasionally the drug -itself- may precipitate cataract formation. Accelerated formation of cataract, has previously been shown as a possible cause of decreased visual acuity, in some cases who received intravitreal injections of triamcinolone. However, no prospective study has, as yet, assessed anti-VEGF agent related cataract progression in cases of AMD. Herein, the investigators have investigated the cataractogenic effect of intravitreal ranibizumab by using the Lens Opacity Classification System III (LOCS III).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Neovascular age-related macular degeneration cases undergoing ranibizumab treatment

• Phakic patients

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Cataract
• Macular Degeneration

Locations

Country	Name	City	State
Turkey	Uludag University School of Medicine, Department of Ophthalmology	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Jonas JB, Kreissig I, Degenring RF. Cataract surgery after intravitreal injection of triamcinolone acetonide. Eye (Lond). 2004 Apr;18(4):361-4. — View Citation

Jonas JB. Intravitreal triamcinolone acetonide: a change in a paradigm. Ophthalmic Res. 2006;38(4):218-45. Epub 2006 Jun 6. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Best corrected visual acuity	Best corrected visual acuity of each individual is recorded	change from baseline in LOCS III grades at 12 months are recorded	No