Extensive Macular Atrophy With Pseudodrusen (EMAP)Phase 1/2RETINA-PRPNCT07341919
Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases
A Phase 1/2 study testing Subtenon Injection of Autologous Platelet-Rich Plasma in people with Extensive Macular Atrophy With Pseudodrusen (EMAP) and Retinitis Pigmentosa (RP), run by Rubens Camargo Siqueira at 1 site in Brazil.
Trial summary
his prospective, comparative pilot study investigates the safety and functional outcomes of subtenon autologous platelet-rich plasma (PRP) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extensive Macular Atrophy With Pseudodrusen (EMAP), Retinitis Pigmentosa (RP)
- What is being tested?
- Subtenon Injection of Autologous Platelet-Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jan 2025to 4 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Clinical diagnosis of retinitis pigmentosa (RP) or EMAP (Extensive Macular Atrophy with Pseudodrusen-like Appearance), confirmed by multimodal evaluation.
- Best-corrected visual acuity (BCVA) ≥ counting fingers at 1 meter (approximately ≤ 1.9 logMAR) in the study eye.
- Measurable visual field on iCare COMPASS (10-2 or 24-2) with acceptable reliability indices.
- Clear ocular media adequate for safe intravitreal injection and high-quality optical coherence tomography (OCT) imaging.
- Ability and willingness to provide written informed consent.
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- Ability to comply with scheduled study visits, including:
- Baseline (M0)
- Day 7-14 after injections
- Month 2 (M2), Day 7-14
- Month 4 (M4), Day 7-14
- Month 6 (M6)
- For ERG subset only:
- o Presence of a recordable baseline 30-Hz flicker electroretinogram (ERG) response, defined as a signal-to-noise ratio ≥ 3:1 and amplitude ≥ 3.0 μV.
- Note: Absence of a measurable flicker ERG response does not exclude participation in the main study.
Who cannot join
- Active ocular inflammation (anterior, intermediate, or posterior uveitis) or active infectious ocular disease in the study eye.
- Active choroidal neovascularization or other macular diseases unrelated to RP or EMAP.
- Uncontrolled glaucoma (intraocular pressure > 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP.
- Significant media opacity that may impair imaging quality or compromise the safety of intravitreal injection.
- Recent ocular interventions that may confound study outcomes, including:
- Intravitreal therapy within 3 months prior to enrollment.
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- Periocular corticosteroid injection within 3 months prior to enrollment.
- Major intraocular surgery within 3 months prior to enrollment.
- Known hypersensitivity to adalimumab, povidone-iodine, local anesthetics, or any component of the study formulations.
- Coagulopathy or contraindications to ocular injections, including:
- Platelet count < 100,000/μL, or
- INR > 1.5 unless adequately corrected.
- Pregnancy or breastfeeding.
- Women of childbearing potential unwilling to use effective contraception during the study period.
- Uncontrolled systemic disease that, in the investigator's judgment, increases risk or interferes with study participation or completion.
- Participation in another interventional clinical trial within 3 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Especializado Retina e Vítreo
São José do Rio Preto, São Paulo, 15010-100
About this study
Official title: Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study
his prospective, comparative pilot study investigates the safety and functional outcomes of subtenon autologous platelet-rich plasma (PRP) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP).
Participants will receive three subtenon injections of autologous platelet-rich plasma (1.5 mL per injection) administered at two-month intervals (M0, M2, M4).
Read more
The primary objective is to assess functional changes over a 6-month period, with a focus on visual field preservation, evaluated by the Field Preservation Deviation Index (FPDI) and Mean Deviation (MD), as well as best-corrected visual acuity (BCVA, LogMAR).
Secondary outcomes include changes in 30-Hz flicker electroretinography (ERG) amplitude, structural retinal parameters on optical coherence tomography (OCT)-including central macular thickness and ellipsoid zone length-and ocular safety outcomes, such as intraocular pressure, local tolerability, and the occurrence of inflammatory or adverse events related to subtenon PRP administration.
Read the detailed description
Retinitis pigmentosa (RP) is a genetically and phenotypically heterogeneous group of inherited retinal dystrophies characterized by progressive degeneration of photoreceptors, typically initiating with rod dysfunction and followed by secondary cone involvement. This process leads to nyctalopia, progressive constriction of the visual field, and, in advanced stages, impairment of central vision. Although recent advances in gene-specific and cell-based therapies have expanded treatment possibilities for selected subgroups, the majority of patients with RP still lack broadly applicable therapeutic approaches capable of modifying disease progression.
Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP) is a distinct degenerative macular phenotype characterized by early-onset bilateral macular atrophy associated with pseudodrusen-like deposits, progressive loss of the outer retina and retinal pigment epithelium, and marked chorioretinal thinning. Despite its phenotypic differences from classical inherited retinal dystrophies, EMAP shares several pathobiological mechanisms with RP, including photoreceptor degeneration, outer retinal ischemia, chronic para-inflammatory activity, microglial activation, and progressive macular atrophy, ultimately resulting in severe central vision loss.
Accumulating experimental and clinical evidence suggests that both RP and EMAP are driven not only by primary degenerative mechanisms but also by sustained para-inflammatory processes at the level of the outer retina, retinal pigment epithelium, and choroid. Dysregulation of microglial activity, oxidative stress, complement activation, and chronic release of inflammatory mediators may contribute to secondary neuronal damage and accelerate structural and functional decline. These shared biological pathways provide a rationale for exploring therapeutic strategies with combined neurotrophic, anti-inflammatory, and tissue-supportive effects.
Autologous platelet-rich plasma (PRP) has emerged as a potential multimodal biologic therapy due to its high concentration of endogenous growth factors and cytokines, including platelet-derived growth factor, transforming growth factor-beta, insulin-like growth factor-1, basic fibroblast growth factor, and other bioactive mediators. These factors may support retinal homeostasis by modulating inflammatory signaling, enhancing chorioretinal perfusion, and promoting cellular survival pathways within the neuroretina and retinal pigment epithelium.
The subtenon route of administration was selected to enable gradual diffusion of PRP-derived bioactive factors toward the posterior segment while minimizing risks associated with intravitreal delivery. This approach is particularly suited for chronic degenerative retinal diseases, where safety, repeatability, and long-term tolerability are essential considerations.
This prospective pilot study was designed to assess the feasibility and ocular safety of repeated subtenon administration of autologous PRP in patients with RP and EMAP, while exploring functional and structural signals over a defined follow-up period. By integrating multimodal functional and imaging assessments, the study aims to generate preliminary data to inform the design of future controlled clinical trials evaluating regenerative and immunomodulatory strategies for inherited and degenerative retinal disorders characterized by progressive photoreceptor loss and macular atrophy.
- Being tested
- Subtenon Injection of Autologous Platelet-Rich Plasma
- Keywords
- Retinitis pigmentosa, EMAP, Macular Atrophy, Pseudodrusen-like, platelet-rich plasma, PRP
- Medical subject headings
- Retinitis Pigmentosa, Anetoderma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtenon Injection of Autologous Platelet-Rich PlasmaBiological
Also called PRP
Biological: Subtenon Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4).
| Study group | Role | What they receive |
|---|---|---|
| Subtenon Injection of Autologous Platelet-Rich Plasma | Experimental | Experimental: Subtenon Injection of Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4).
This arm evaluates the effect of local autologous regenerative and immunomodulatory therapy on visual function and retinal structure in patients with degenerative retinal diseases, including Retinitis Pigmentosa and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). Receives: Biological: Subtenon Injection of Autologous Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Field Preservation Deviation Index (FPDI)
Change (Δ) in Field Preservation Deviation Index (FPDI), expressed as a percentage (%), measured by automated perimetry using the iCare COMPASS system. The FPDI reflects the proportion of preserved visual field relative to age-matched normative data and provides a quantitative assessment of global visual field integrity. The outcome is defined as the difference between baseline (Month 0) and Month 6 values in the study eye.
Measured: Baseline to Month 6
. Change in Mean Deviation (MD)
Change (Δ) in Mean Deviation (MD), expressed in decibels (dB), measured by automated perimetry using the iCare COMPASS system. Mean Deviation represents the average difference in retinal sensitivity compared with age-adjusted normative values, serving as a global index of visual field loss. The outcome corresponds to the difference between baseline (Month 0) and Month 6 measurements in the study eye.
Measured: Baseline to Month 6
. Change in Best-Corrected Visual Acuity (BCVA)
Change (Δ) in Best-Corrected Visual Acuity (BCVA), expressed in logarithm of the minimum angle of resolution (LogMAR), measured using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) charts under controlled testing conditions. BCVA assesses central visual function and foveal integrity. The outcome is defined as the difference between baseline (Month 0) and Month 6 BCVA values in the study eye.
Measured: Baseline to Month 6
Secondary outcomes (4)
Change in Pattern Standard Deviation (PSD)
Change (Δ) in Pattern Standard Deviation (PSD), expressed in decibels (dB), measured by automated perimetry using the iCare COMPASS system. PSD reflects localized irregularities in visual field sensitivity and is particularly sensitive to focal or non-uniform patterns of visual field loss. The outcome is defined as the difference between baseline (Month 0) and Month 6 measurements in the study eye.
Measured: Baseline to Month 6]
Change in 30-Hz Flicker ERG Amplitude
Change (Δ) in 30-Hz flicker electroretinogram (ERG) amplitude, expressed in microvolts (µV), measured in accordance with International Society for Clinical Electrophysiology of Vision (ISCEV) standards. The 30-Hz flicker ERG primarily assesses cone-mediated retinal function and provides an objective measure of global photoreceptor and post-receptoral pathway integrity. The outcome corresponds to the difference between baseline (Month 0) and Month 6 values in the study eye.
Measured: Baseline to Month 6
Change in Central Macular Thickness (CMT)
Change (Δ) in central macular thickness (CMT), expressed in micrometers (µm), measured by spectral-domain optical coherence tomography (SD-OCT). CMT represents the average retinal thickness within the central macular subfield and serves as a structural biomarker of macular integrity, including retinal edema, atrophy, or remodeling. The outcome is defined as the difference between baseline (Month 0) and Month 6 measurements in the study eye.
Measured: Baseline to Month 6
Change in Ellipsoid Zone (EZ) Length
Change (Δ) in ellipsoid zone (EZ) length, expressed in micrometers (µm), measured by spectral-domain optical coherence tomography (SD-OCT). EZ length reflects the integrity and spatial extent of photoreceptor inner segment ellipsoid band and is a sensitive structural biomarker of photoreceptor preservation in degenerative retinal diseases. The outcome corresponds to the difference between baseline (Month 0) and Month 6 measurements in the study eye.
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start4 Jan 2025
- Primary completion4 Mar 2026
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive Macular Atrophy With Pseudodrusen (EMAP)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, open-label interventional pilot study designed to assess the ocular safety, feasibility, and functional outcomes of subtenon administration of autologous platelet-rich plasma (PRP) in patients with degenerative retinal diseases. All participants receive three subtenon injections of autologous PRP (1.5 mL per injection) administered at baseline (M0) and at two-month intervals (M2, M4). Given the exploratory nature of the study and the heterogeneity of degenerative retinal diseases, no randomization or masking is applied. Each participant serves as their own control, with outcomes evaluated as within-subject changes from baseline to six months (M0-M6). The study aims to provide proof-of-concept data on the regenerative and immunomodulatory potential of PRP, focusing on functional outcomes and OCT-based biomarkers, to support the design of future controlled trials.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubens Camargo Siqueira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rubens Camargo Siqueira, Centro de Pesquisa Rubens Siqueira
- Investigators
- Rubens C Siqueira, MD,PhD, Principal investigator, Rubens Siqueira Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341919
- Sponsor's protocol ID
- RETINA-PRP Study
- Acronym
- RETINA-PRP
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siqueira RC, Brandao CC, Souza ACJ, Seixas JR, Balbino MA, Antunes LM, Oliveira CM, Pinho TS, Cruz PF. Subtenon Autologous Platelet-Rich Plasma in Degenerative Retinal Diseases: A Prospective Pilot Study of Safety and Exploratory Functional Signals in Retinitis Pigmentosa and EMAP. Biomedicines. 2026 Apr 30;14(5):1029. doi: 10.3390/biomedicines14051029.
PubMed 42193355
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study
- ClinicalTrials.gov ID
- NCT07341919
- Acronym / sponsor ID
- RETINA-PRP / RETINA-PRP Study
- Keywords
- Retinitis pigmentosa, EMAP, Macular Atrophy, Pseudodrusen-like, platelet-rich plasma, PRP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rubens Camargo SiqueiraUniversity, hospital or other
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 14 Jan 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.
his prospective, comparative pilot study investigates the safety and functional outcomes of subtenon autologous platelet-rich plasma (PRP) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP).
Participants will receive three subtenon injections of autologous platelet-rich plasma (1.5 mL per injection) administered at two-month intervals (M0, M2, M4).
The primary objective is to assess functional changes over a 6-month period, with a focus on visual field preservation, evaluated by the Field Preservation Deviation Index (FPDI) and Mean Deviation (MD), as well as best-corrected visual acuity (BCVA, LogMAR).
Secondary outcomes include changes in 30-Hz flicker electroretinography (ERG) amplitude, structural retinal parameters on optical coherence tomography (OCT)-including central macular thickness and ellipsoid zone length-and ocular safety outcomes, such as intraocular pressure, local tolerability, and the occurrence of inflammatory or adverse events related to subtenon PRP administration.
Detailed description
Retinitis pigmentosa (RP) is a genetically and phenotypically heterogeneous group of inherited retinal dystrophies characterized by progressive degeneration of photoreceptors, typically initiating with rod dysfunction and followed by secondary cone involvement. This process leads to nyctalopia, progressive constriction of the visual field, and, in advanced stages, impairment of central vision. Although recent advances in gene-specific and cell-based therapies have expanded treatment possibilities for selected subgroups, the majority of patients with RP still lack broadly applicable therapeutic approaches capable of modifying disease progression.
Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP) is a distinct degenerative macular phenotype characterized by early-onset bilateral macular atrophy associated with pseudodrusen-like deposits, progressive loss of the outer retina and retinal pigment epithelium, and marked chorioretinal thinning. Despite its phenotypic differences from classical inherited retinal dystrophies, EMAP shares several pathobiological mechanisms with RP, including photoreceptor degeneration, outer retinal ischemia, chronic para-inflammatory activity, microglial activation, and progressive macular atrophy, ultimately resulting in severe central vision loss.
Accumulating experimental and clinical evidence suggests that both RP and EMAP are driven not only by primary degenerative mechanisms but also by sustained para-inflammatory processes at the level of the outer retina, retinal pigment epithelium, and choroid. Dysregulation of microglial activity, oxidative stress, complement activation, and chronic release of inflammatory mediators may contribute to secondary neuronal damage and accelerate structural and functional decline. These shared biological pathways provide a rationale for exploring therapeutic strategies with combined neurotrophic, anti-inflammatory, and tissue-supportive effects.
Autologous platelet-rich plasma (PRP) has emerged as a potential multimodal biologic therapy due to its high concentration of endogenous growth factors and cytokines, including platelet-derived growth factor, transforming growth factor-beta, insulin-like growth factor-1, basic fibroblast growth factor, and other bioactive mediators. These factors may support retinal homeostasis by modulating inflammatory signaling, enhancing chorioretinal perfusion, and promoting cellular survival pathways within the neuroretina and retinal pigment epithelium.
The subtenon route of administration was selected to enable gradual diffusion of PRP-derived bioactive factors toward the posterior segment while minimizing risks associated with intravitreal delivery. This approach is particularly suited for chronic degenerative retinal diseases, where safety, repeatability, and long-term tolerability are essential considerations.
This prospective pilot study was designed to assess the feasibility and ocular safety of repeated subtenon administration of autologous PRP in patients with RP and EMAP, while exploring functional and structural signals over a defined follow-up period. By integrating multimodal functional and imaging assessments, the study aims to generate preliminary data to inform the design of future controlled clinical trials evaluating regenerative and immunomodulatory strategies for inherited and degenerative retinal disorders characterized by progressive photoreceptor loss and macular atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, open-label interventional pilot study designed to assess the ocular safety, feasibility, and functional outcomes of subtenon administration of autologous platelet-rich plasma (PRP) in patients with degenerative retinal diseases. All participants receive three subtenon injections of autologous PRP (1.5 mL per injection) administered at baseline (M0) and at two-month intervals (M2, M4). Given the exploratory nature of the study and the heterogeneity of degenerative retinal diseases, no randomization or masking is applied. Each participant serves as their own control, with outcomes evaluated as within-subject changes from baseline to six months (M0-M6). The study aims to provide proof-of-concept data on the regenerative and immunomodulatory potential of PRP, focusing on functional outcomes and OCT-based biomarkers, to support the design of future controlled trials.
| Arm | Type | Receives |
|---|---|---|
| Subtenon Injection of Autologous Platelet-Rich Plasma | Experimental | Biological: Subtenon Injection of Autologous Platelet-Rich PlasmaExperimental: Subtenon Injection of Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4). This arm evaluates the effect of local autologous regenerative and immunomodulatory therapy on visual function and retinal structure in patients with degenerative retinal diseases, including Retinitis Pigmentosa and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years.
- Clinical diagnosis of retinitis pigmentosa (RP) or EMAP (Extensive Macular Atrophy with Pseudodrusen-like Appearance), confirmed by multimodal evaluation.
- Best-corrected visual acuity (BCVA) ≥ counting fingers at 1 meter (approximately ≤ 1.9 logMAR) in the study eye.
- Measurable visual field on iCare COMPASS (10-2 or 24-2) with acceptable reliability indices.
- Clear ocular media adequate for safe intravitreal injection and high-quality optical coherence tomography (OCT) imaging.
Key exclusion criteria (16 listed)
- Active ocular inflammation (anterior, intermediate, or posterior uveitis) or active infectious ocular disease in the study eye.
- Active choroidal neovascularization or other macular diseases unrelated to RP or EMAP.
- Uncontrolled glaucoma (intraocular pressure > 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP.
- Significant media opacity that may impair imaging quality or compromise the safety of intravitreal injection.
- Recent ocular interventions that may confound study outcomes, including:
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 Injection of Autologous Platelet-Rich PlasmaAlso: PRPBiological: Subtenon Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4). | Biological | Subtenon Injection of Autologous Platelet-Rich Plasma |
Primary outcome
Change in Field Preservation Deviation Index (FPDI)
Time frame: Baseline to Month 6
Change (Δ) in Field Preservation Deviation Index (FPDI), expressed as a percentage (%), measured by automated perimetry using the iCare COMPASS system. The FPDI reflects the proportion of preserved visual field relative to age-matched normative data and provides a quantitative assessment of global visual field integrity. The outcome is defined as the difference between baseline (Month 0) and Month 6 values in the study eye.
. Change in Mean Deviation (MD)
Time frame: Baseline to Month 6
Change (Δ) in Mean Deviation (MD), expressed in decibels (dB), measured by automated perimetry using the iCare COMPASS system. Mean Deviation represents the average difference in retinal sensitivity compared with age-adjusted normative values, serving as a global index of visual field loss. The outcome corresponds to the difference between baseline (Month 0) and Month 6 measurements in the study eye.
. Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline to Month 6
Change (Δ) in Best-Corrected Visual Acuity (BCVA), expressed in logarithm of the minimum angle of resolution (LogMAR), measured using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) charts under controlled testing conditions. BCVA assesses central visual function and foveal integrity. The outcome is defined as the difference between baseline (Month 0) and Month 6 BCVA values in the study eye.
4 secondary outcomes
Change in Pattern Standard Deviation (PSD)
Time frame: Baseline to Month 6]
Change in 30-Hz Flicker ERG Amplitude
Time frame: Baseline to Month 6
Change in Central Macular Thickness (CMT)
Time frame: Baseline to Month 6
Change in Ellipsoid Zone (EZ) Length
Time frame: Baseline to Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publication: PubMed 42193355Siqueira RC, Brandao CC, Souza ACJ, Seixas JR, Balbino MA, Antunes LM, Oliveira CM, Pinho TS, Cruz PF. Subtenon Autologous Platelet-Rich Plasma in Degenerative Retinal Diseases: A Prospective Pilot Study of Safety and Exploratory Functional Signals in Retinitis Pigmentosa and EMAP. Biomedicines. 2026 Apr 30;14(5):1029. doi: 10.3390/biomedicines14051029.
- Individual participant dataSharing planned: Undecided
Related trials for Extensive Macular Atrophy With Pseudodrusen (EMAP)
Active, not recruitingPhase 1/2
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Retinitis Pigmentosa (RP), Extensive Macular Atrophy With Pseudodrusen (EMAP)
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.
Rubens C Siqueira, MD,PhD principal investigator
Rubens Siqueira Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Subtenon Injection of Autologous Platelet-Rich Plasma in people with Extensive Macular Atrophy With Pseudodrusen (EMAP) and Retinitis Pigmentosa (RP), run by Rubens Camargo Siqueira at 1 site in Brazil.
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 15 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 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 Brazil. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Field Preservation Deviation Index (FPDI) (time frame: Baseline to Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341919, which also lists 1 linked publication.
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 1 Jul 2026.