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Completed

NCT Number: NCT04982484

Reading Speed Improvements in Wet-AMD Patients After Ranibizumab Treatment

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.

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Key information

Conditions

Ophthalmopathy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Wet Macular Degeneration

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AMD, Age related macular degeneration (Wet-form)

Exclusion criteria

  • Age related macular degeneration (Dry-form)
  • Diabetic macular oedema
  • Other related macular oedemas

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Visual acuity using the ETDRS chart day 0

    Time frame: 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.

  2. Visual acuity using the ETDRS chartM3

    Time frame: month 3

    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.

  3. Maculare thickness Day0

    Time frame: day 0

    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.

  4. Maculare thickness M3

    Time frame: Month 3

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Collaborators

  • University of Pecs

Registry information

Official study title

Effects of Anti-VEGF Injections (Ranibizumab, Lucentis) on Visual Acuity, Reading Speed and Retinal Thickness in Wet-AMD Patients

Acronym: PAMER

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2021
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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