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CompletedNCT03492853Updated Apr 10, 2018

The Association of the Peripheral Retinal Changes and Genotypic Changes in Patients With Age Related Macular Degeneration

An observational study in Peripheral Retinal Degenerations, Age Related Macular Degeneration Polymorphisms, sponsored by University Hospital Sestre Milosrdnice. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by University Hospital Sestre Milosrdnice · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
310
Ages
50 Years and older
Sex
All
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Study summary

Purpose: To examine the genotypes associated with the peripheral retinal phenotypic features in patients with age-related macular degeneration documented with wide-field imaging.

Design: Clinic-based case series study in Croatia. Participants: 160 patients >50 years of age known to have early or advanced AMD and 150 subjects >50 years of age without known AMD (controls) Methods: Both groups of patients were examined with ophthalmoscopy and OCT to confirm their classification. Posterior and peripheral fundus features were documented with Optos wide-field imaging (Optos P200MA, Optos Plc, Dunfermline, Scotland) and graded. DNA was extracted from blood samples and gene polymorphisms were evaluated for complement factor H (CFH) rs1061170 and rs1410996, age-related maculopathy susceptibility (ARMS2) rs10490924, high temperature requirement factor A1 (HtrA1) rs11200638, complement factor B (CFB) rs4151667 and rs641153, complement factor 2 (C2) rs9332739 and rs547154 and complement factor 3 (C3) rs2230199.

Read the detailed description

Purpose: To examine the genotypes associated with the peripheral retinal phenotypic features in patients with age-related macular degeneration documented with wide-field imaging.

Design: Clinic-based case series study in Croatia. Participants: Using standard protocols, 160 patients >50 years of age known to have early or advanced AMD and 150 subjects >50 years of age without known AMD (controls) were studied.

Materials and methods: Both groups of patients were examined with ophthalmoscopy and OCT to confirm their classification. Posterior and peripheral fundus features were documented with Optos wide-field imaging (Optos P200MA, Optos Plc, Dunfermline, Scotland) and graded. DNA was extracted from blood samples and gene polymorphisms were evaluated for complement factor H (CFH) rs1061170 and rs1410996, age-related maculopathy susceptibility (ARMS2) rs10490924, high temperature requirement factor A1 (HtrA1) rs11200638, complement factor B (CFB) rs4151667 and rs641153, complement factor 2 (C2) rs9332739 and rs547154 and complement factor 3 (C3) rs2230199.

The study cohort was identified among the clinical patients at the University Department of Ophthalmology at University Hospital Centre "Sestre milosrdnice", Zagreb, Croatia. The protocol was approved by the Ethics Committee approval (EP-13030/11-13) of the University Hospital Centre "Sestre milosrdnice" and complied with the tenets of the Declaration of Helsinki with the informed consent obtained from all the participants. We included 160 subjects in AMD group and 150 subjects in the control group who met the following criteria: age exceeding 50 years, clinical signs of AMD in at least one eye in AMD group and without signs of the disease in the control group. Exclusion criteria were as follows: confounding maculopathy of any etiology, having a myopic refractive error more than -3.0 diopters in either eye, failure to obtain readable color images documenting at least 270 degrees of the retina (three quadrants), or failure to provide a peripheral blood sample for DNA extraction. All the participants were examined according to standardized examination protocols where the macular region and retinal periphery were photodocumented with Resmax and wide field imaging respectively using the Optos P200MA camera (Optos plc, Dumfermline Scotland).23 Phenotypes Eligibility for the AMD group was determined according to an international classification of AMD.24,25 The retinal periphery was defined as an extramacular area 6000 µm diameter distant from the foveolar centre and a grid template was used for measuring the distance. Following peripheral retinal phenotypes were documented: peripheral drusen, reticular pigmentations (RP), hyperpigmentations (pigment clumping (PC) or nevus (N)), hypopigmentations (peripheral retinal pigment defects (RPD) or atrophic areas (AA)), other degenerations in aggregate (OD) which include any of the following: microcystoid degenerations with degenerative retinoschisis (RD), lattice degenerations (LD), snail-track degeneration (ST), white-without pressure (WWP), paving stone degeneration(also known as cobblestone) (PS), retinal holes (R) and vitreal opacities (VO). The inclusion criteria for the peripheral retinal change was its size which had to exceed at least one hour of the retinal periphery Main outcome measures: The type, localization and frequency of peripheral retinal changes and gene polymorphisms of participants in both groups were examined.

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Conditions studied

  • Peripheral Retinal Degenerations, Age Related Macular Degeneration Polymorphisms
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In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's enrollment of 310 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University Hospital Sestre Milosrdnice is the lead sponsor of 27 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

We included 160 subjects in AMD group and 150 subjects in the control group who met the following criteria: age exceeding 50 years, clinical signs of AMD in at least one eye in AMD group and without signs of the disease in the control group. Exclusion criteria were as follows: confounding maculopathy of any etiology, having a myopic refractive error more than -3.0 diopters in either eye, failure to obtain readable color images documenting at least 270 degrees of the retina (three quadrants), or failure to provide a peripheral blood sample for DNA extraction. All the participants were examined according to standardized examination protocols where the macular region and retinal periphery were photodocumented with Resmax and wide field imaging respectively using the Optos P200MA camera (Optos plc, Dumfermline Scotland).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • in AMD group-patients with the signs of AMD disease

Exclusion criteria

Exclusion Criteria:

  • confounding maculopathy of any etiology, having a myopic refractive error more than -3.0 diopters in either eye, failure to obtain readable color images documenting at least 270 degrees of the retina (three quadrants), or failure to provide a peripheral blood sample for DNA extraction
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
310 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • patients with AMD

    150 patients with age related macular degeneration more than 50 years old who will have retina photodocumented and genotyped for AMD SNP's

    Genetic: DNA extraction and sequencing

  • control group

    150 patients in control group without the clinical signs of the disease more than 50 years old who will have retina photodocumented and genotyped for AMD SNP's

    Genetic: DNA extraction and sequencing

Interventions

  • GeneticDNA extraction and sequencing

    DNA extraction from peripheral blood and KASP sequencing

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What researchers measure

Primary outcomes

  1. the association of the peripheral retina changes and genotyping

    the association between those two parameters

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Sep 2016, 20 months.

Of 105 non-industry observational studies under Macular Degeneration, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 98. This study's 20 months is below that.

Counting every sponsor, half of 161 studies reached it within 45 months; a quarter within 16 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 10, 2018
StartActual
Jan 1, 2015
Primary completionActual
Sep 20, 2016
CompletionActual
Dec 29, 2016
Last update
Apr 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03492853
Lead sponsor
University Hospital Sestre Milosrdnice
Responsible party
Tamara Knezevic (medical doctor, ophthalmologist, University Hospital Sestre Milosrdnice) — Principal investigator
First posted
Apr 10, 2018
Start date
Jan 1, 2015
Primary completion
Sep 20, 2016
Completion
Dec 29, 2016
Last update
Apr 10, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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