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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in Retina Pigment Epithelium Atrophy Area (mm²)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 60 years
- •Diagnosis of advanced dry age-related macular degeneration (AMD) in both eyes
- •No previous ocular treatment for AMD
- •History of ocular surgery limited to cataract surgery performed ≥1 year prior
Exclusion Criteria
- •Media opacities interfering with retinal imaging assessment
- •Any ocular disease other than dry AMD that could affect retinal structure or function
- •Evidence of macular neovascularization
- •Previous intraocular surgery other than cataract surgery
- •Systemic or ocular conditions that could affect study compliance or visual testing reliability
Arms & Interventions
PRP-Treated Eye
The better-seeing eye receives three subtenon injections of autologous platelet-rich plasma (PRP) at 4-week intervals. This arm is used to evaluate the effect of PRP treatment on the progression of geographic atrophy and visual function parameters over the follow-up period.
Intervention: Subtenon Autologous Platelet-Rich Plasma Injection (Procedure)
Untreated Fellow Eye
The fellow eye does not receive PRP treatment and is followed according to the same evaluation schedule. This arm serves as a within-subject comparison to assess the natural course of geographic atrophy and changes in visual function over time.
Outcomes
Primary Outcomes
Change in Retina Pigment Epithelium Atrophy Area (mm²)
Time Frame: Baseline (Week 0) to 2 weeks after the third PRP injection (Week 10)
Retina pigment epithelium (RPE) atrophy area will be quantified using both fundus autofluorescence (FAF) and optical coherence tomography (OCT). OCT measurements will be performed using a previously validated deep learning-based automated algorithm (RetInSight GA Monitor), and FAF measurements will be obtained using semi-automated image analysis software (RegionFinder). Changes in RPE atrophy area (mm²) will be compared between the PRP-treated eye and the fellow untreated eye.
Retina Pigment Epithelium Atrophy Growth Rate (Square root transformed, mm/year)
Time Frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Retina pigment epithelium (RPE) atrophy growth rates will be calculated from square root transformed lesion areas to reduce bias related to baseline lesion size. Growth rates derived from square-root-transformed areas will be expressed in millimeters per year (mm/year). Growth rates will be compared between the PRP-treated eye and the fellow untreated eye.
Change in Photoreceptor Loss Area (mm²)
Time Frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Photoreceptor loss area (mm²) will be quantified using optical coherence tomography (OCT). Measurements will be performed using a previously validated deep learning-based automated algorithm (RetInSight GA Monitor). Changes in photoreceptor loss area (mm²) will be compared between the PRP-treated eye and the fellow untreated eye.
Photoreceptor Loss Growth Rate (Square root transformed, mm/year)
Time Frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Photoreceptor loss growth rates will be calculated from square root transformed lesion areas to reduce bias related to baseline lesion size. Growth rates derived from square root transformed areas will be expressed in millimeters per year (mm/year). Growth rates will be compared between the PRP-treated eye and the fellow untreated eye.
Secondary Outcomes
- Change in Best-Corrected Visual Acuity(Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection))
- Change in Reading Performance(Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection))
- Change in Multifocal Electroretinography P1-Wave Amplitude(Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection))
- Change in Multifocal Electroretinography P1-Wave Implicit Time(Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection))
- Change in Vision-Related Quality of Life (NEI-VFQ-25 Score)(Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection))
Investigators
Nimet Zeynep Tıraş
Principal Investigator
Marmara University Pendik Training and Research Hospital