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TGF-ßs in the eye of patients with neovascular age-related macular degeneration

TGF-ß concentrations and activity in the aqueous humor of patients with neovascular age-related macular degeneration before and after ranibizumab treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN60434145
Enrollment
40
Registered
2018-01-12
Start date
2016-06-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration (AMD) Eye Diseases Age-related macular degeneration (AMD)

Interventions

We measure the concentrations of active TGF-ß1, TGF-ß2, and TGF-ß3 by ELISA in the aqueous humor of patients affected by nAMD, who received 3 consecutive monthly intravitreal injections of ranibizumab

Sponsors

University of Siena
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
There were no secondary outcomes of interest.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026