Trials / Completed
CompletedNCT07428798
Subtenon PRP Injection for Geographic Atrophy in Dry Age-Related Macular Degeneration
Effects of Subtenon Autologous Platelet-Rich Plasma Injection on Geographic Atrophy Progression, Visual Function, and Quality of Life in Advanced Dry Age-Related Macular Degeneration
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Marmara University Pendik Training and Research Hospital · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates the effects of subtenon autologous platelet-rich plasma (PRP) injections on retinal structure and visual function in patients with advanced dry age-related macular degeneration (AMD). PRP is derived from the patient's own blood and contains growth factors that may support cell survival and tissue repair. These factors are thought to help reduce retinal cell loss and slow disease progression. Three PRP injections were administered to the better-seeing eye at 4-week intervals, while the fellow eye served as an untreated control. Participants were followed from baseline to 10 weeks (two weeks after the third injection). The aim is to compare changes in RPE atrophy area, photoreceptor loss, and visual function between treated and untreated eyes.
Detailed description
Age-related macular degeneration (AMD) is a leading cause of irreversible vision loss in the elderly population. Geographic atrophy (GA), the advanced form of dry AMD, is characterized by progressive loss of the retinal pigment epithelium (RPE), photoreceptors, and choriocapillaris, resulting in gradual decline of visual function. Current treatment options for GA remain limited, and therapeutic strategies aimed at slowing retinal neurodegeneration represent an important unmet clinical need. Platelet-rich plasma (PRP) is an autologous blood-derived product containing multiple growth factors, including platelet-derived growth factor (PDGF), insulin-like growth factor-1 (IGF-1), epidermal growth factor (EGF), transforming growth factor-β (TGF-β), hepatocyte growth factor (HGF), and basic fibroblast growth factor (bFGF). These bioactive molecules are associated with neuroprotective, anti-apoptotic, and regenerative effects in various tissues. This prospective, controlled, intra-individual comparative study evaluates the effects of subtenon autologous PRP injections on structural and functional outcomes in patients with advanced dry AMD with GA. In each participant, the eye with better baseline visual acuity received treatment, while the fellow eye served as an untreated control. Three subtenon PRP injections were administered at 4-week intervals, and patients were followed from baseline to 10 weeks, corresponding to two weeks after the third injection. Structural outcomes were evaluated based on RPE atrophy and photoreceptor loss area. RPE atrophy area was measured using both fundus autofluorescence (FAF) imaging and optical coherence tomography (OCT), whereas photoreceptor loss area was assessed using OCT. OCT measurements were performed using validated deep learning-based segmentation software, while FAF measurements were obtained using semi-automated image analysis. Visual function was evaluated through best-corrected visual acuity (BCVA), MNREAD reading performance parameters, and multifocal electroretinography (mfERG). Vision-related quality of life was assessed using the NEI VFQ-25 questionnaire. Changes in structural and functional parameters were compared between PRP-treated eyes and untreated fellow eyes. This study investigates whether subtenon PRP administration may slow retinal structural degeneration and help preserve visual function in patients with GA secondary to dry AMD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Subtenon Autologous Platelet-Rich Plasma Injection | Autologous platelet-rich plasma prepared from the participant's peripheral blood is administered via subtenon injection under sterile conditions. Each treated eye receives three injections at monthly intervals. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2024-10-30
- Completion
- 2024-10-30
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07428798. Inclusion in this directory is not an endorsement.