Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)

• Sponsor: Retina Foundation of the Southwest (Other)
• Overall Status: Completed
• CT.gov ID: NCT03322930
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

A new fundus-guided microperimeter (MP-3S) has been developed by Nidek, Inc. to track the fundus of the patient and present stimuli in specific anatomically-defined locations. Furthermore, this tracking means that exactly the same locations can be tested on subsequent (follow-up) visits. The investigators will use a method called two-color perimetry to map rod and cone sensitivity on this device. With this technique, the sensitivity difference (blue-red) to chromatic test stimuli can be used to determine whether rods, cones or both photoreceptor systems mediate the threshold at a given location in the macula.

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa; AMD	Diagnostic Test: Rod sensitivity

Detailed Description

Despite recent advances in understanding the pathogenesis of retinitis pigmentosa (RP) and age-related macular degeneration (AMD), precise characterization of the disease phenotype remains elusive. In both diseases, much of the focus has necessarily been on the loss of cone function, since visual fields, acuity and contrast sensitivity are typically measured under photopic conditions. In RP, we need a greater understanding of patterns of rod loss since most disease-causing mutations affect primarily rods. In AMD, recent findings have shown that scotopic sensitivity can be much more affected than conventional photopic measurements such as visual acuity. For patients, however, it is difficult to maintain stable fixation, especially when central vision is compromised. A new fundus-guided microperimeter, the MP-3S, has been developed by Nidek, Inc. to circumvent this problem. The investigators will evaluate the value of this device for following rod and cone loss in patients with either RP or AMD.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Retinitis Pigmentosa patients with a diagnosis of retinitis pigmentosa and reduced rod function on baseline testing	Diagnostic Test: Rod sensitivity; diagnostic test for rod loss in central retina
Age-related Macular Degeneration patients with a diagnosis of intermediate AMD and reduced rod function on baseline testing	Diagnostic Test: Rod sensitivity; diagnostic test for rod loss in central retina

Outcome Measures

Primary Outcome Measures

1. Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S [through study completion, an average of 1 year]

   Number of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• clear media

• diagnosis of RP or non neovascular AMD

• normal volunteers

Exclusion Criteria:

• exudative AMD

• other eye diseases that could cause vision loss

• physical ailments that would preclude comfortable testing

• unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Foundation of the Southwest	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Retina Foundation of the Southwest

Investigators

• Principal Investigator: David G Birch, PhD, Retina Foundation of the Southwest

Study Documents (Full-Text)

• Study Protocol - Oct 24, 2018

More Information

Additional Information:

• Retina Foundation of the Southwest website

Publications

None provided.

• Responsible Party: Retina Foundation of the Southwest
• ClinicalTrials.gov Identifier: NCT03322930
• Other Study ID Numbers: STU082017-084
• First Posted: Oct 26, 2017
• Last Update Posted: Dec 23, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Retina Foundation of the Southwest: microperimetry; rod visual fields
• Additional relevant MeSH terms: Macular Degeneration; Retinitis; Retinitis Pigmentosa

Study Results

Participant Flow

Recruitment Details	patients recruited from medical clinic (Texas Retina Associates)

Arm/Group Title	Patients With a Diagnosis of Retinitis Pigmentosa	Patients With Intermediate Age-related Macular Degeneration
Arm/Group Description	patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina	patients with a diagnosis of intermediate AMD Rod sensitivity: diagnostic test for rod loss in central retina
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Patients With a Diagnosis of Retinitis Pigmentosa	Patients With a Diagnosis of Intermediate AMD	Total
Arm/Group Description	patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina	patients with a diagnosis of intermediate AMD Rod sensitivity: diagnostic test for rod loss in central retina	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	5 25%	25 62.5%
>=65 years	0 0%	15 75%	15 37.5%
Sex: Female, Male (Count of Participants)
Female	12 60%	15 75%	27 67.5%
Male	8 40%	5 25%	13 32.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%	0 0%	2 5%
Not Hispanic or Latino	18 90%	20 100%	38 95%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 10%	0 0%	2 5%
Asian	3 15%	2 10%	5 12.5%
Native Hawaiian or Other Pacific Islander	1 5%	0 0%	1 2.5%
Black or African American	2 10%	1 5%	3 7.5%
White	12 60%	17 85%	29 72.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S
Description	Number of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina
Time Frame	through study completion, an average of 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With a Diagnosis of Retinitis Pigmentosa	Patients With a Diagnosis of Intermediate AMD
Arm/Group Description	patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina	patients with a diagnosis of intermediate AMD Rod sensitivity: diagnostic test for rod loss in central retina
Measure Participants	20	20
Count of Participants [Participants]	7 35%	20 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients With a Diagnosis of Retinitis Pigmentosa, Patients With a Diagnosis of Intermediate AMD
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	calculated from data
	Method	t-test, 2 sided
	Comments
Other Statistical Analysis		mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient

Adverse Events

Time Frame	1 year
Arm/Group Title	Patients With a Diagnosis of Retinitis Pigmentosa		Patients With a Diagnosis of Intermediate AMD
Arm/Group Description	patients with a diagnosis of retinitis pigmentosa Rod sensitivity: diagnostic test for rod loss in central retina		patients with a diagnosis of intermediate AMD Rod sensitivity: diagnostic test for rod loss in central retina
All Cause Mortality
	Patients With a Diagnosis of Retinitis Pigmentosa		Patients With a Diagnosis of Intermediate AMD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Patients With a Diagnosis of Retinitis Pigmentosa		Patients With a Diagnosis of Intermediate AMD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Patients With a Diagnosis of Retinitis Pigmentosa		Patients With a Diagnosis of Intermediate AMD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.