OphthalmopathyPAMERNCT04982484
Reading Speed Improvements in Wet-AMD Patients After Ranibizumab Treatment
An observational study of Ophthalmopathy and Wet Macular Degeneration, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
AMD (age-related macular degeneration), is the leading cause of blindness in individuals over the age of 55. There is no cure for wet-AMD but anti-VEGF treatments significantly minimize the vision loss over time. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ophthalmopathy, Wet Macular Degeneration
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2010to 1 Aug 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Macular oedema due to WET-AMD
Who may be able to join
- AMD, Age related macular degeneration (Wet-form)
Who cannot join
- Age related macular degeneration (Dry-form)
- Diabetic macular oedema
- Other related macular oedemas
About this study
Official title: Effects of Anti-VEGF Injections (Ranibizumab, Lucentis) on Visual Acuity, Reading Speed and Retinal Thickness in Wet-AMD Patients
AMD (age-related macular degeneration), is the leading cause of blindness in individuals over the age of 55. There is no cure for wet-AMD but anti-VEGF treatments significantly minimize the vision loss over time. To study the correlation between anti-VEGF injection bevacizumab (Lucentis), visual acuity, macular thickness and last but not least reading speed in wet-AMD patients.
The study was conducted on 50 eyes of 50 wet-AMD patients. Subjects were monthly treated with an intra-vitreal Lucentis injection for 3 months; further injections were given when a loss of 5 or more letters of visual acuity was observed and/or when the retinal thickness in the affected macular area increased by 100 µm. In addition to a full ophthalmological examination reading speed was investigated via the Radner reading chart before and 3 months after treatment. The collected data was analyzed using paired t-tests.
Read the detailed description
Age related macular degeneration also known as AMD is the most common cause of blindness in Europe, the USA and other industrialized countries. AMD appears in people above the age of 50. The origin despite intensive research and many clinical trials is not fully understood. However, it is assumed that AMD is multifactorial. It has metabolic, genetic and environmental components that play crucial roles in the development of the disease. The interaction of different etiologic risk factors in chronic changes in the macular area (choroid, Bruch's membrane, and retinal pigment epithelium) is reflected in a slowly progressive loss of vision. AMD is classified into a dry and a wet form. The dry form represents 80% of all AMDs and it only leads to blindness in 10% of the cases. Dry AMD is characterized by drusen, pigmentary changes (hypo/hyper-pigmentation and-or atrophy of the photoreceptors with the RPE and the choriocapillaries as well). A successful therapy for this form is still unknown, but studies have shown that a change in lifestyle and dietary supplements (vitamins) can slow the progression of the disease. The wet form represents 20% of AMDs, but in 80-90% of the cases patients may experience rapid and serious vision loss. The vision loss is due to the formation of abnormal blood vessels, which are leaking in the choroid because they have no barrier and cause accumulation of blood and fluid in the intraretinal and/or subretinal space and ultimately leading to an irreversible scarring stage (Kuhnt-Junius scar). Against wet-AMD, there are numerous treatment possibilities, and they are very efficient. The treatment is mainly on the basis of anti-angiogenesis, the anti-vascular endothelial growth factor drug (Anti-VEGF) comes as an intravitreal injection ranibizumab (Lucentis). With only a few articles focusing on the reading speeds as a criteria in patients with macular disorders, analyses of the evolution of the reading speed of Wet-AMD patients are needed before and after Lucentis injections with the use Radner's reading chart : The Radner reading chart is a highly standardized multilingual reading test system that was developed in 1998 for clinical practice.
- Conditions
- Ophthalmopathy, Wet Macular Degeneration
- Medical subject headings
- Eye Diseases, Wet Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed day 0
Reading speed measurement via Radner reading chart (a highly standardized multilingual reading test system that was developed for clinical practice and research) We measured reading speed on 50 patients before and 3 months after treatment. The reading chart consists of "sentence optotypes", which are optimized reading test items, standardized by construction and statistical selection. Sentence optotypes consist of short sentences that are highly comparable in terms of number of words (14 words), word length, and position of words, lexical difficulty and syntactical complexity. Language specific characteristics were taken into account as were the number of letters and syllables per word, line, and sentence. The advantage of such sentence optotypes is that they minimize variations between test items and keep the geometric proportions constant.
Measured: day 0
Reading speed M3
Reading speed measurement via Radner reading chart (a highly standardized multilingual reading test system that was developed for clinical practice and research) We measured reading speed on 50 patients before and 3 months after treatment. The reading chart consists of "sentence optotypes", which are optimized reading test items, standardized by construction and statistical selection. Sentence optotypes consist of short sentences that are highly comparable in terms of number of words (14 words), word length, and position of words, lexical difficulty and syntactical complexity. Language specific characteristics were taken into account as were the number of letters and syllables per word, line, and sentence. The advantage of such sentence optotypes is that they minimize variations between test items and keep the geometric proportions constant.
Measured: month 3
Secondary outcomes (4)
Visual acuity using the ETDRS chart day 0
ETDRS stands for the Early Treatment of Diabetic Retinopathy Study. This landmark study helped to define the standardization of eye charts and visual acuity testing, resulting in the development of these ETDRS charts. The charts use ETDRS letters, or a geometric progression in letter size from line to line, each line being of equal difficulty.
The ETDRS chart format has been accepted by the National Eye Institute and the FDA, and is mandated for many clinical trials performed worldwide. It is accepted worldwide as today's Gold Standard for accurate visual acuity measurement. ETDRS scoring can be accomplished in a number of different ways. The most common method is when the patient starts at the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified.
Measured: day 0
Visual acuity using the ETDRS chartM3
ETDRS stands for the Early Treatment of Diabetic Retinopathy Study. This landmark study helped to define the standardization of eye charts and visual acuity testing, resulting in the development of these ETDRS charts. The charts use ETDRS letters, or a geometric progression in letter size from line to line, each line being of equal difficulty.
The ETDRS chart format has been accepted by the National Eye Institute and the FDA, and is mandated for many clinical trials performed worldwide. It is accepted worldwide as today's Gold Standard for accurate visual acuity measurement. ETDRS scoring can be accomplished in a number of different ways. The most common method is when the patient starts at the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified.
Measured: month 3
Maculare thickness Day0
Optical coherence tomography (OCT) is a non-invasive imaging test that provides anteroposterior images by measuring the echo time and intensity of reflected or backscattered light from intraretinal microstructures.
With OCT, each of the retina's distinctive layers can be seen, allowing us to map and measure their thickness.
Measured: day 0
Maculare thickness M3
Optical coherence tomography (OCT) is a non-invasive imaging test that provides anteroposterior images by measuring the echo time and intensity of reflected or backscattered light from intraretinal microstructures.
With OCT, each of the retina's distinctive layers can be seen, allowing us to map and measure their thickness.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Sep 2010
- Primary completion1 Jun 2013
- Study completion1 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmopathyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pecs
- Responsible party
- Sponsor
- Investigators
- Georges Jr Hayek, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982484
- Sponsor's protocol ID
- 2010-01-UPMS
- Acronym
- PAMER
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-VEGF Injections (Ranibizumab, Lucentis) on Visual Acuity, Reading Speed and Retinal Thickness in Wet-AMD Patients
- ClinicalTrials.gov ID
- NCT04982484
- Acronym / sponsor ID
- PAMER / 2010-01-UPMS
- Conditions
- Ophthalmopathy, Wet Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- University of Pecs
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Aug 2013 (actual)
- First posted
- 29 Jul 2021 (actual)
- 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.
AMD (age-related macular degeneration), is the leading cause of blindness in individuals over the age of 55. There is no cure for wet-AMD but anti-VEGF treatments significantly minimize the vision loss over time. To study the correlation between anti-VEGF injection bevacizumab (Lucentis), visual acuity, macular thickness and last but not least reading speed in wet-AMD patients.
The study was conducted on 50 eyes of 50 wet-AMD patients. Subjects were monthly treated with an intra-vitreal Lucentis injection for 3 months; further injections were given when a loss of 5 or more letters of visual acuity was observed and/or when the retinal thickness in the affected macular area increased by 100 µm. In addition to a full ophthalmological examination reading speed was investigated via the Radner reading chart before and 3 months after treatment. The collected data was analyzed using paired t-tests.
Detailed description
Age related macular degeneration also known as AMD is the most common cause of blindness in Europe, the USA and other industrialized countries. AMD appears in people above the age of 50. The origin despite intensive research and many clinical trials is not fully understood. However, it is assumed that AMD is multifactorial. It has metabolic, genetic and environmental components that play crucial roles in the development of the disease. The interaction of different etiologic risk factors in chronic changes in the macular area (choroid, Bruch's membrane, and retinal pigment epithelium) is reflected in a slowly progressive loss of vision. AMD is classified into a dry and a wet form. The dry form represents 80% of all AMDs and it only leads to blindness in 10% of the cases. Dry AMD is characterized by drusen, pigmentary changes (hypo/hyper-pigmentation and-or atrophy of the photoreceptors with the RPE and the choriocapillaries as well). A successful therapy for this form is still unknown, but studies have shown that a change in lifestyle and dietary supplements (vitamins) can slow the progression of the disease. The wet form represents 20% of AMDs, but in 80-90% of the cases patients may experience rapid and serious vision loss. The vision loss is due to the formation of abnormal blood vessels, which are leaking in the choroid because they have no barrier and cause accumulation of blood and fluid in the intraretinal and/or subretinal space and ultimately leading to an irreversible scarring stage (Kuhnt-Junius scar). Against wet-AMD, there are numerous treatment possibilities, and they are very efficient. The treatment is mainly on the basis of anti-angiogenesis, the anti-vascular endothelial growth factor drug (Anti-VEGF) comes as an intravitreal injection ranibizumab (Lucentis). With only a few articles focusing on the reading speeds as a criteria in patients with macular disorders, analyses of the evolution of the reading speed of Wet-AMD patients are needed before and after Lucentis injections with the use Radner's reading chart : The Radner reading chart is a highly standardized multilingual reading test system that was developed in 1998 for clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Macular oedema due to WET-AMD
Key inclusion criteria (1 listed)
- AMD, Age related macular degeneration (Wet-form)
Key exclusion criteria (3 listed)
- Age related macular degeneration (Dry-form)
- Diabetic macular oedema
- Other related macular oedemas
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
Reading speed day 0
Time frame: day 0
Reading speed measurement via Radner reading chart (a highly standardized multilingual reading test system that was developed for clinical practice and research) We measured reading speed on 50 patients before and 3 months after treatment. The reading chart consists of "sentence optotypes", which are optimized reading test items, standardized by construction and statistical selection. Sentence optotypes consist of short sentences that are highly comparable in terms of number of words (14 words), word length, and position of words, lexical difficulty and syntactical complexity. Language specific characteristics were taken into account as were the number of letters and syllables per word, line, and sentence. The advantage of such sentence optotypes is that they minimize variations between test items and keep the geometric proportions constant.
Reading speed M3
Time frame: month 3
Reading speed measurement via Radner reading chart (a highly standardized multilingual reading test system that was developed for clinical practice and research) We measured reading speed on 50 patients before and 3 months after treatment. The reading chart consists of "sentence optotypes", which are optimized reading test items, standardized by construction and statistical selection. Sentence optotypes consist of short sentences that are highly comparable in terms of number of words (14 words), word length, and position of words, lexical difficulty and syntactical complexity. Language specific characteristics were taken into account as were the number of letters and syllables per word, line, and sentence. The advantage of such sentence optotypes is that they minimize variations between test items and keep the geometric proportions constant.
4 secondary outcomes
Visual acuity using the ETDRS chart day 0
Time frame: day 0
Visual acuity using the ETDRS chartM3
Time frame: month 3
Maculare thickness Day0
Time frame: day 0
Maculare thickness M3
Time frame: Month 3
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 29 Jul 2021.
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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.
Georges Jr Hayek, MD principal investigator
CHR Metz Thionville Hopital de Mercy
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmopathy and Wet Macular Degeneration, run by Centre Hospitalier Régional Metz-Thionville.
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 1 inclusion and 3 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 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Reading speed day 0 (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.