CompletedNot Applicable

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

Turkey (Türkiye)14 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Retina Pigment Epithelium Atrophy Area (mm²)

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

Retina Pigment Epithelium Atrophy Growth Rate (Square root transformed, mm/year)

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

Change in Photoreceptor Loss Area (mm²)

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

Photoreceptor Loss Growth Rate (Square root transformed, mm/year)

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

Trial details

NCT IDNCT07428798

SponsorMarmara University Pendik Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-30

View on ClinicalTrials.gov More Geographic Atrophy trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Retina Pigment Epithelium Atrophy Area (mm²)

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

Retina Pigment Epithelium Atrophy Growth Rate (Square root transformed, mm/year)

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

Change in Photoreceptor Loss Area (mm²)

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

Photoreceptor Loss Growth Rate (Square root transformed, mm/year)

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