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

This study has been completed.
Sponsor:
Information provided by:
Uludag University
ClinicalTrials.gov Identifier:
NCT01330797
First received: April 4, 2011
Last updated: April 6, 2011
Last verified: January 2011
  Purpose

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.


Condition
Age-Related Macular Degeneration
Cataract

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effect of Ranibizumab on Eye Lens Opacity in Cases With Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Uludag University:

Primary Outcome Measures:
  • Lens Opacity Classification System (LOCS) III grades [ Time Frame: Change from baseline in LOCS III grades at 12 months are recorded. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: change from baseline in LOCS III grades at 12 months are recorded ] [ Designated as safety issue: No ]
    Best corrected visual acuity of each individual is recorded


Enrollment: 13
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
LOCS III
Cohort is composed of cases with a diagnosis of wet age-related macular degeneration and those that received intravitreal ranibizumab

Detailed 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).

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neovascular age-related macular degeneration cases undergoing ranibizumab treatment

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330797

Locations
Turkey
Uludag University School of Medicine, Department of Ophthalmology
Bursa, Turkey, 16059
Sponsors and Collaborators
Uludag University
Investigators
Principal Investigator: Mehmet Baykara, M.D Uludag University School of Medicine, Department Of Ophthalmlogy
  More Information