Clinical trial NCT03935126: Global Atrophie Biomarker Evaluation Study (GABiE)
Official title: 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-OCT in Assessing Changes in Retinal Sensitivity and Anatomy Over Time.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age-related Macular Degeneration
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 3
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) who are not receiving treatment for GA and have not previously receiving active treatment in clinical trials in the indication under invesitigation will be enrolled and followed for up to 12 months.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: At baseline and at week 12.
measure: 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
timeFrame: At baseline and at week 12.
measure: 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
timeFrame: At baseline and at week 12.
Secondary outcomes:
measure: 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
timeFrame: At baseline and at week 24 and 48.
measure: 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
timeFrame: At baseline and at week 24 and 48.
measure: 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
timeFrame: At baseline and at week 24 and 48.
measure: Change From Baseline in the GA Area as Measured by Fundus Autofluorescence (FAF) at Week 12, 24 and 48
timeFrame: At baseline and at week 12, 24 and 48
measure: 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
timeFrame: At baseline and at week 12, 24 and 48.
measure: 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
timeFrame: At baseline and at week 12, 24 and 48.
measure: Number of Scotomatous Points Assessed by Microperimetry at Week 12, 24 and 48
timeFrame: At week 12, 24 and 48
measure: 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
timeFrame: At baseline and at week 12, 24 and 48.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References: