Age-related macular degeneration (AMD) Eye Diseases Age-related macular degeneration (AMD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Case inclusion criteria: 1. Both males and females 2. Patients aged 50 and over 3. Able to provide written, informed consent to the study 4. Active neovascular AMD in study eye with evidence of leakage from CNV on fluorescein angiography. Control inclusion criteria: 1. Both males and females 2. Patients aged 50 and over, the age of the controls is chosen not to have statistical differences with the cases 3. Able to provide written, informed consent to the study 4. Patients in the waiting list for cataract surgery
Exclusion criteria
Exclusion criteria: CASE exclusion criteria: 1. Prior treatment for neovascular age-related macular degeneration 2. Age less than 50 years old 3. Inability to comply with the study or follow up 4. Inability to perform fluorescein angiography 5. Axial length greater than 26 mm 6. Any previous ophthalmic surgery except cataract removal ( cataract surgery had to have been performed at least 9 months prior to inclusion) 7. Any other ocular disease other than neovascular age-related macular degeneration 8. Diabetes mellitus, use of immunosuppressive drugs and a malignant tumor in any location Control exclusion criteria: 1. Any other ocular disease other than cataract 2. Any previous ophthalmic surgery 3. Age less than 50 years old 4. Axial length greater than 26 mm 5. Diabetes mellitus, use of immunosuppressive drugs and a malignant tumor in any location
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. TGF-beta concentration is measured using ELISA kits for human TGF-ß1, TGF-ß2 (Quantikine ELISA kits #DB100B and #DB250, respectively; R&D Systems, Minneapolis, USA) and TGF-ß3 (#SEB949Hu; Cloud-Clone Corp., Houston, TX) at baseline, 1 month and 2 months (Only baseline for controls) 2. TGF-ß pathway activation is measured using the transfection of Lenti-X 293T cells and the Nano-Glo® Dual-Luciferase® Reporter Assay System (#N1610; Promega Corp., Madison, WI) at baseline, 1 month and 2 months (only baseline for controls) | — |
Secondary
| Measure | Time frame |
|---|---|
| There were no secondary outcomes of interest. | — |
Countries
Italy