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

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ClinicalTrials.gov Identifier: NCT03492853
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Tamara Knezevic, University Hospital "Sestre Milosrdnice"

Tracking Information
First Submitted Date April 2, 2018
First Posted Date April 10, 2018
Last Update Posted Date April 10, 2018
Actual Study Start Date January 1, 2015
Actual Primary Completion Date September 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2018)
the association of the peripheral retina changes and genotyping [ Time Frame: 2 years ]
the association between those two parameters
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Association of the Peripheral Retinal Changes and Genotypic Changes in Patients With Age Related Macular Degeneration
Official Title The Association of the Peripheral Retinal Changes and Genotypic Changes in Patients With Age Related Macular Degeneration
Brief 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.

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
The DNA was extracted from peripheral blood and then sequenced for SNP's.
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).
Condition Peripheral Retinal Degenerations, Age Related Macular Degeneration Polymorphisms
Intervention Genetic: DNA extraction and sequencing
DNA extraction from peripheral blood and KASP sequencing
Study Groups/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
    Intervention: 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
    Intervention: Genetic: DNA extraction and sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 2, 2018)
310
Original Actual Enrollment Same as current
Actual Study Completion Date December 29, 2016
Actual Primary Completion Date September 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03492853
Other Study ID Numbers UHSestre1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tamara Knezevic, University Hospital "Sestre Milosrdnice"
Study Sponsor University Hospital "Sestre Milosrdnice"
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital "Sestre Milosrdnice"
Verification Date April 2018