Age-Related Macular DegenerationNCT01330797
The Effect of Ranibizumab on Eye Lens Opacity in Cases With Age-Related Macular Degeneration
An observational study of Age-Related Macular Degeneration and Cataract, run by Uludag University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Age-Related Macular Degeneration, Cataract
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neovascular age-related macular degeneration cases undergoing ranibizumab treatment
Who may be able to join
- Neovascular age-related macular degeneration cases undergoing ranibizumab treatment
- Phakic patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uludag University School of Medicine, Department of Ophthalmology
Bursa, 16059
About this study
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.
Read more
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.
Read the 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).
- Conditions
- Age-Related Macular Degeneration, Cataract
- Keywords
- Cataract, Intravitreal, Ranibizumab, LOCS III
- Medical subject headings
- Macular Degeneration, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LOCS III | Cohort is composed of cases with a diagnosis of wet age-related macular degeneration and those that received intravitreal ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in LOCS III grades at 12 months are recorded.
Secondary outcomes (1)
Best corrected visual acuity
Best corrected visual acuity of each individual is recorded
Measured: change from baseline in LOCS III grades at 12 months are recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Investigators
- Mehmet Baykara, M.D, Principal investigator, Uludag University School of Medicine, Department Of Ophthalmlogy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330797
- Sponsor's protocol ID
- GOZ-1
- Status last verified
- Jan 2011
- First submitted
- 4 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sampat KM, Garg SJ. Complications of intravitreal injections. Curr Opin Ophthalmol. 2010 May;21(3):178-83. doi: 10.1097/ICU.0b013e328338679a.
PubMed 20375895Jonas JB. Intravitreal triamcinolone acetonide: a change in a paradigm. Ophthalmic Res. 2006;38(4):218-45. doi: 10.1159/000093796. Epub 2006 Jun 6.
PubMed 16763379Jonas 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.
PubMed 15069430Regillo 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.
PubMed 18222192Chylack 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.
PubMed 19085579
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ranibizumab on Eye Lens Opacity in Cases With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01330797
- Acronym / sponsor ID
- GOZ-1
- Conditions
- Age-Related Macular Degeneration, Cataract
- Keywords
- Cataract, Intravitreal, Ranibizumab, LOCS III
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOCS III | – | –Cohort is composed of cases with a diagnosis of wet age-related macular degeneration and those that received intravitreal ranibizumab |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neovascular age-related macular degeneration cases undergoing ranibizumab treatment
Key inclusion criteria (2 listed)
- Neovascular age-related macular degeneration cases undergoing ranibizumab treatment
- Phakic patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Best corrected visual acuity
Time frame: change from baseline in LOCS III grades at 12 months are recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Background: PubMed 20375895Sampat KM, Garg SJ. Complications of intravitreal injections. Curr Opin Ophthalmol. 2010 May;21(3):178-83. doi: 10.1097/ICU.0b013e328338679a.
- Background: PubMed 16763379Jonas JB. Intravitreal triamcinolone acetonide: a change in a paradigm. Ophthalmic Res. 2006;38(4):218-45. doi: 10.1159/000093796. Epub 2006 Jun 6.
- Background: PubMed 15069430Jonas 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.
- Background: PubMed 18222192Regillo 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.
- Background: PubMed 19085579Chylack 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.
Related trials for Age-Related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Baykara, M.D principal investigator
Uludag University School of Medicine, Department Of Ophthalmlogy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration and Cataract, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lens Opacity Classification System (LOCS) III grades (time frame: Change from baseline in LOCS III grades at 12 months are recorded.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330797, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.