Age-related Macular Degeneration
Conditions
Brief summary
To investigate the use of microperimetry and SS-OCT in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.
Interventions
DIAGNOSTIC_TESTDiagnostics
Diagnostics
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study * Age \>=60 years * Ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye * GA lesion in the study eye must reside completely within the FAF imaging field (Field 2- 30 degree image centered on the fovea) * BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye * Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye * The total GA lesion size \>=1.2 mm\^2 (approximately \>=0.5 disc area \[DA\]) and \<=17.78 mm\^2 (approximately \<=7 DA) and must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea) * If GA is multifocal, at least 1 focal lesion must be \>=1.2 mm\^2 (approximately \>=0.5 DA) * Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye
Exclusion criteria
* GA in either eye due to causes other than AMD (for example, monogenetic macular dystrophies \[e.g., Stargardt disease, cone rod dystrophy\] or toxic maculopathies \[e.g., chloroquine/hydroxychloroquine maculopathy\]) * Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye * Mean sensitivity difference \> 3 dB between the two microperimetry examinations in the screening visit. * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye * Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye * Prior treatment with Visudyne ®, external-beam radiation therapy, or transpupillary thermotherapy in the study eye * History of prophylactic subthreshold laser treatment for AMD in the study eye * Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Retinal Sensitivity in the Junctional Zone and in the Perilesional Zone of the Largest Atrophic Loci as Assessed by Microperimetry for the Evaluation of Macular Functional Response at Week 12 | At baseline and at week 12. |
| Change From Baseline in Retinal Pigment Epithelium (RPE) Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 12 | At baseline and at week 12. |
| Change From Baseline in Photoreceptor Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 12 | At baseline and at week 12. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in the GA Area as Measured by Fundus Autofluorescence (FAF) at Week 12, 24 and 48 | At baseline and at week 12, 24 and 48 |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Scale (ETDRS) Chart at a Starting Distance of 4 Meters at Week 12, 24 and 48 | At baseline and at week 12, 24 and 48. |
| Change From Baseline in Retinal Sensitivity in the Junctional Zone and in the Perilesional Zone of the Largest Atrophic Loci as Assessed by Microperimetry at Week 24 and 48 | At baseline and at week 24 and 48. |
| Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48 | At week 12, 24 and 48 |
| Change From Baseline in the Area of Choroidal Non-perfusion as Measured Via Optical Coherence Tomography Angiography (OCT-A) at Week 12, 24 and 48 | At baseline and at week 12, 24 and 48. |
| Change From Baseline in Low Luminance Visual Acuity (LLVA) Score as Assessed by ETDRS Chart Under Low Luminance Conditions at a Starting Distance of 4 Meters at Week 12, 24 and 48 | At baseline and at week 12, 24 and 48. |
| Change From Baseline in Retinal Pigment Epithelium (RPE) Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 24 and 48 | At baseline and at week 24 and 48. |
| Change From Baseline in Photoreceptor Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 24 and 48 | At baseline and at week 24 and 48. |
Countries
Switzerland, United States
Participant flow
Recruitment details
A biomarker evaluation study in patients with geographic atrophy secondary to age-related macular degeneration (AMD) evaluating the use of microperimetry (fundus-controlled perimetry) and Swept Source-Optical Coherence Tomography in assessing changes in retinal sensitivity and anatomy over observation period of 48 weeks.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled All enrolled participants who had geographic atrophy secondary to age-related macular degeneration, signed informed consent for this trial, and met all inclusion criteria and none of the exclusion criteria, for evaluating the usage of microperimetry and Swept Source - Optical Coherence Tomography (SS-OCT) in assessing the natural changes of retinal sensitivity and anatomy in the retina. Each participant was planned to be observed for an observation period of 48 weeks after screening visit. During the observation period, 4 visits were planned to be taken at Week 0, 12, 24, and 48 of the observation period. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study termination by sponsor | 3 |
Baseline characteristics
| Characteristic | All Enrolled |
|---|---|
| Age, Continuous | 83.7 Years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change From Baseline in Photoreceptor Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 12
Time frame: At baseline and at week 12.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Primary
Change From Baseline in Retinal Pigment Epithelium (RPE) Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 12
Time frame: At baseline and at week 12.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Primary
Change From Baseline in Retinal Sensitivity in the Junctional Zone and in the Perilesional Zone of the Largest Atrophic Loci as Assessed by Microperimetry for the Evaluation of Macular Functional Response at Week 12
Time frame: At baseline and at week 12.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Scale (ETDRS) Chart at a Starting Distance of 4 Meters at Week 12, 24 and 48
Time frame: At baseline and at week 12, 24 and 48.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in Low Luminance Visual Acuity (LLVA) Score as Assessed by ETDRS Chart Under Low Luminance Conditions at a Starting Distance of 4 Meters at Week 12, 24 and 48
Time frame: At baseline and at week 12, 24 and 48.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in Photoreceptor Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 24 and 48
Time frame: At baseline and at week 24 and 48.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in Retinal Pigment Epithelium (RPE) Layer Thickness in the Junctional Zone and in the Perilesional Zone as Measured by Swept Source - Optical Coherence Tomography (SS-OCT) at Week 24 and 48
Time frame: At baseline and at week 24 and 48.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in Retinal Sensitivity in the Junctional Zone and in the Perilesional Zone of the Largest Atrophic Loci as Assessed by Microperimetry at Week 24 and 48
Time frame: At baseline and at week 24 and 48.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in the Area of Choroidal Non-perfusion as Measured Via Optical Coherence Tomography Angiography (OCT-A) at Week 12, 24 and 48
Time frame: At baseline and at week 12, 24 and 48.
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Change From Baseline in the GA Area as Measured by Fundus Autofluorescence (FAF) at Week 12, 24 and 48
Time frame: At baseline and at week 12, 24 and 48
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.
Secondary
Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48
Time frame: At week 12, 24 and 48
Population: Study was terminated early. 3 subjects were enrolled but no subject was entered. No outcome measures data was collected.