Trial Outcomes & Findings for Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration (NCT NCT01115231)

Results Overview

Assessment of Age based on clinical records.

Recruitment status

COMPLETED

Target enrollment

223 participants

Primary outcome timeframe

baseline visit

Results posted on

2019-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 (Control) Case control subjects without AMD diagnosis.	Group 2 (Age-related Macular Degeneration) Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
Overall Study STARTED	133	90
Overall Study COMPLETED	133	90
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Complement Factor H Haplotypes and Smoking in Age-related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Control) n=133 Participants Case control subjects without AMD diagnosis.	Group 2 (Age-related Macular Degeneration) n=90 Participants Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.	Total n=223 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	7 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	100 Participants n=5 Participants	83 Participants n=7 Participants	183 Participants n=5 Participants
Age, Continuous	70.6 years STANDARD_DEVIATION 6.3 • n=5 Participants	77.8 years STANDARD_DEVIATION 8.33 • n=7 Participants	73.5 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	52 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	38 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · European	81 Participants n=5 Participants	83 Participants n=7 Participants	164 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	52 Participants n=5 Participants	7 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United States	133 Participants n=5 Participants	90 Participants n=7 Participants	223 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline visit

Assessment of Age based on clinical records.

Outcome measures

Outcome measures
Measure	Group 1 (Control) n=133 Participants Case control subjects without AMD diagnosis.	Group 2 (Age-related Macular Degeneration) n=90 Participants Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
Age in Study Participants	70.6 years Standard Deviation 6.3	77.8 years Standard Deviation 8.33

SECONDARY outcome

Timeframe: Day 1 of study

Patients were asked during patient interview as to their history of smoking (current, never or ever was assessed).

Outcome measures

Outcome measures
Measure	Group 1 (Control) n=133 Participants Case control subjects without AMD diagnosis.	Group 2 (Age-related Macular Degeneration) n=90 Participants Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
Number of Participants That Are Smokers	34 Participants	31 Participants

SECONDARY outcome

Timeframe: Blood sample collection at contact

Population: Participants of European descent

To assess for risk of AMD. Cells remaining from the serum separation were used for genetic analysis. Genomic DNA was extracted using a commercially available DNA extraction kit according to the manufacturer's instructions (QIAmp® DNA Mini; Qiagen). The AMD-associated SNP was genotyped at CFH (rs3766404), locus using PCR-based assays (TaqMan assays, Applied Biosystems), according to the manufacturer's instructions. Only white Caucasians in the population were included.

Outcome measures

Outcome measures
Measure	Group 1 (Control) n=81 Participants Case control subjects without AMD diagnosis.	Group 2 (Age-related Macular Degeneration) n=83 Participants Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
Number of Participants With Signal Nucleotide Polymorphisms for CFH Locus	20 Participants	10 Participants

SECONDARY outcome

Timeframe: within a month of obtaining blood sample

Population: Multivariate analyses were conducted through the use of general linear mixed models. The models did include random subject effects to account for dependence among repeated measurements of subjects. This type of model is ideal when there are multiple measurements on subjects, such as when laboratory measurements are performed in triplicate.

To assess systemic complement activation, venus blood is collected. Complement component analysis was performed as a fee for service at the National Jewish Health Advanced Diagnostic Laboratories, using commercially available kits. Samples were analyzed in two batches in which the ELISA displayed difference sensitivities. Therefore data was normalized within each batch to values obtained from control subjects. Data reported represents the average of the two batches.

Outcome measures

Outcome measures
Measure	Group 1 (Control) n=133 Participants Case control subjects without AMD diagnosis.	Group 2 (Age-related Macular Degeneration) n=90 Participants Case (i.e., within 5 years) subjects will be recruited. Cases are defined as subjects with diagnosed AMD.
Percentage of Complement Pathway Proteins in the Serum C3a	95.3 percentage of control Standard Deviation 34.3	113.1 percentage of control Standard Deviation 58.8
Percentage of Complement Pathway Proteins in the Serum C5a	103.7 percentage of control Standard Deviation 23.9	93.1 percentage of control Standard Deviation 24.4
Percentage of Complement Pathway Proteins in the Serum Bb	94.7 percentage of control Standard Deviation 42.5	116.6 percentage of control Standard Deviation 71.5
Percentage of Complement Pathway Proteins in the Serum CFH activity	98.3 percentage of control Standard Deviation 52.1	104.8 percentage of control Standard Deviation 63.2

Adverse Events

Group 1 (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 (Age-related Macular Degeneration)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Baerbel Rohrer, PhD; VA Research Scientist

Ralph H. Johnson VA Medical Center, Division of Research, Charleston, SC, USA

Phone: 843-792-5086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place