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

April 6, 2011 updated by: Uludag University

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 Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16059
        • Uludag University School of Medicine, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neovascular age-related macular degeneration cases undergoing ranibizumab treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lens Opacity Classification System (LOCS) III grades
Time Frame: Change from baseline in LOCS III grades at 12 months are recorded.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: change from baseline in LOCS III grades at 12 months are recorded
Best corrected visual acuity of each individual is recorded
change from baseline in LOCS III grades at 12 months are recorded

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Principal Investigator: Mehmet Baykara, M.D, Uludag University School of Medicine, Department Of Ophthalmlogy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (ESTIMATE)

April 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOZ-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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