A study to compare JNJ-81201887 to a sham procedure for the treatment of geographic atrophy secondary to age-related macular degeneratio
- Conditions
- Geographic atrophy, secondary to age-related macular degenerationEye Diseases
- Registration Number
- ISRCTN38641780
- Lead Sponsor
- Janssen (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 300
Current inclusion criteria as of 27/08/2024:
1. Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT).
2. If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5- disc area), as assessed by the CRC
3. GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC.
4. Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better.
5.Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)
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Previous inclusion criteria:
1. 60 years of age or older
2. Have non-subfoveal (defined as not involving the center point of the fovea) GA secondary to AMD with an area measuring 2.5 mm2 to 17.5 mm2 (1 and 7 disc areas respectively), determined by the CRC from screening images of FAF and SD-OCT.
3. A woman of childbearing potential must have a negative highly sensitive serum (ß-human chorionic gonadotropin) test for the sample collected at Screening and a negative urine pregnancy test on Day 4 before receiving the study intervention.
4. Must sign an ICF (or their legally-acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in and able to complete all required assessments during the study.
Current exclusion criteria as of 27/08/2024:
1. History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
2. Any prior thermal laser in the macular region, regardless of indication
3. History of retinal detachment (with or without repair)
4. Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
5. Any sign of diabetic retinopathy or central serous chorioretinopathy
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Previous exclusion criteria:
1. History of or presence of retinal disease other than GA: diabetic retinopathy, central serous chorioretinopathy, inherited retinal degeneration, toxic maculopathies (ie, hydroxychloroquine maculopathy), arterial and venous occlusive disease, macular hole that is present or has been previously repaired, or choroidal melanoma.
2. Presence of macular fibrosis or retinal epithelial tear, clinically relevant myopic degeneration, or vitreous hemorrhage
a. Benign conditions of the vitreous (ie, posterior vitreous detachment) or peripheral retina (ie, paving stone degeneration, lattice degeneration, etc.) are permitted.
3. History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye.
4. Any prior thermal laser in the macular region, regardless of indication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 27/08/2024: <br><br>Change from baseline in square root of geographic atrophy (GA) lesion area in the study eye at Month 18<br><br>_____<br><br>Previous primary outcome measure:<br><br>Change from baseline in square root of geographic atrophy (GA) lesion area in the study eye up to month 18
- Secondary Outcome Measures
Name Time Method