Clinical trial NCT01330797: The Effect of Ranibizumab on Eye Lens Opacity in Cases With Age-Related Macular Degeneration
Official title: The Effect of Ranibizumab on Eye Lens Opacity in Cases With Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Cataract
Keywords: Cataract
Intravitreal
Ranibizumab
LOCS III
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 13
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neovascular age-related macular degeneration cases undergoing ranibizumab treatment

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.

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 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

Primary outcomes:
measure: Lens Opacity Classification System (LOCS) III grades
timeFrame: Change from baseline in LOCS III grades at 12 months are recorded.
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: change from baseline in LOCS III grades at 12 months are recorded
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University School of Medicine, Department of Ophthalmology
Study officials:
affiliation: Uludag University School of Medicine, Department Of Ophthalmlogy
name: Mehmet Baykara, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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