Geographic AtrophyGA-PRPNCT07428798
Subtenon PRP Injection for Geographic Atrophy in Dry Age-Related Macular Degeneration
A study testing Subtenon Autologous Platelet-Rich Plasma Injection in people with Geographic Atrophy and Dry Age Related Macular Degeneration, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geographic Atrophy, Dry Age Related Macular Degeneration
- What is being tested?
- Subtenon Autologous Platelet-Rich Plasma Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine, Department of Ophthalmology
Istanbul, Istanbul, 34899
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Being tested
- Subtenon Autologous Platelet-Rich Plasma Injection
- Keywords
- Age-Related Macular Degeneration, GA Monitor, Geographic Atrophy, RegionFinder, Platelet-Rich Plasma
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtenon Autologous Platelet-Rich Plasma InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP-Treated Eye | Experimental | 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. Receives: Procedure: Subtenon Autologous Platelet-Rich Plasma Injection |
| Untreated Fellow Eye | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retina Pigment Epithelium Atrophy Area (mm²)
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.
Measured: Baseline (Week 0) to 2 weeks after the third PRP injection (Week 10)
Retina Pigment Epithelium Atrophy Growth Rate (Square root transformed, mm/year)
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.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Photoreceptor Loss Area (mm²)
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.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Photoreceptor Loss Growth Rate (Square root transformed, mm/year)
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.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Secondary outcomes (5)
Change in Best-Corrected Visual Acuity
Best-corrected visual acuity (BCVA) will be measured monocularly and binocularly at 6 meters using a Snellen chart and converted to logMAR values for analysis. Changes in BCVA will be compared between baseline and week 10, as well as between the PRP-treated eye and the fellow untreated eye.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Reading Performance
Reading performance will be assessed binocularly using the MNREAD reading test. Parameters include reading acuity (logMAR), critical print size (logMAR), maximum reading speed (words per minute), and reading accessibility index. Changes will be evaluated between baseline and week 10.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Multifocal Electroretinography P1-Wave Amplitude
Multifocal electroretinography (mfERG) P1-wave amplitude (nV) will be analyzed across retinal rings. Changes from baseline to week 10 and differences between treated and fellow untreated eyes will be evaluated.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Multifocal Electroretinography P1-Wave Implicit Time
Multifocal electroretinography (mfERG) P1-wave implicit time (ms) will be analyzed across retinal rings. Changes from baseline to week 10 and differences between treated and fellow untreated eyes will be evaluated.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Vision-Related Quality of Life (NEI-VFQ-25 Score)
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). Subscale scores and overall composite score will be compared between baseline and week 10.
Measured: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jul 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a within-patient, eye-controlled interventional study. In each participant, the eye with better baseline visual acuity received subtenon autologous PRP injections, while the fellow eye served as the untreated control. Outcomes were compared between treated and untreated eyes.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimet Zeynep Tıraş, Marmara University Pendik Training and Research Hospital
- Investigators
- Nimet Zeynep Tıraş, Medical Doctor, Principal investigator, Marmara University Faculty of Medicine, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428798
- Sponsor's protocol ID
- 09.2024.656
- Acronym
- GA-PRP
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07428798
- Acronym / sponsor ID
- GA-PRP / 09.2024.656
- Keywords
- Age-Related Macular Degeneration, GA Monitor, Geographic Atrophy, RegionFinder, Platelet-Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a within-patient, eye-controlled interventional study. In each participant, the eye with better baseline visual acuity received subtenon autologous PRP injections, while the fellow eye served as the untreated control. Outcomes were compared between treated and untreated eyes.
| Arm | Type | Receives |
|---|---|---|
| PRP-Treated Eye | Experimental | Procedure: Subtenon Autologous Platelet-Rich Plasma InjectionThe 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. |
| Untreated Fellow Eye | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtenon Autologous Platelet-Rich Plasma InjectionAutologous 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. | Procedure or surgery | PRP-Treated Eye |
Primary outcome
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.
5 secondary outcomes
Change in Best-Corrected Visual Acuity
Time frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Reading Performance
Time frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Multifocal Electroretinography P1-Wave Amplitude
Time frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Multifocal Electroretinography P1-Wave Implicit Time
Time frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Change in Vision-Related Quality of Life (NEI-VFQ-25 Score)
Time frame: Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimet Zeynep Tıraş, Medical Doctor principal investigator
Marmara University Faculty of Medicine, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtenon Autologous Platelet-Rich Plasma Injection in people with Geographic Atrophy and Dry Age Related Macular Degeneration, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Retina Pigment Epithelium Atrophy Area (mm²) (time frame: Baseline (Week 0) to 2 weeks after the third PRP injection (Week 10)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.