Subtenon PRP Injection for Geographic Atrophy in Dry Age-Related Macular Degeneration

NCT07428798 | Completed

• 1 other identifier: 09.2024.656
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Geographic Atrophy; Dry Age Related Macular Degeneration

Keywords

Age-Related Macular Degeneration; GA Monitor; Geographic Atrophy; RegionFinder; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (Week 0) to Week 10 (2 weeks after the third PRP injection)

Secondary Outcomes (5)

• 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)

Study Arms (2)

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.

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.

Interventions

Subtenon Autologous Platelet-Rich Plasma Injection PROCEDURE

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.

PRP-Treated Eye

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University School of Medicine, Department of Ophthalmology

Istanbul, Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Nimet Zeynep Tıraş, Medical Doctor

  Marmara University Faculty of Medicine, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 24, 2026
• Study Start: July 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

TU (1)