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Retinitis Pigmentosa (RP)Phase 1/2ADARETNCT07348588

Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

A Phase 1/2 study testing Intravitreal Adalimumab in people with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy With Pseudodrusen (EMAP), run by Centro de Pesquisa Rubens Siqueira at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This prospective, comparative pilot study investigates the safety and functional outcomes of intravitreal adalimumab (ADA) 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
What is being tested?
Intravitreal Adalimumab
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
10 Jul 2025to 1 Aug 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 OCT imaging.
  • Ability and willingness to provide written informed consent.
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  • Ability to comply with scheduled study visits (Baseline [M0], Day 7-14 after injections, Month 2 [M2], Day 7-14, Month 4 [M4], Day 7-14, and Month 6 [M6]).
  • For ERG subset only: presence of a recordable baseline 30-Hz flicker ERG response (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 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 safe 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 formulation components.
  • Coagulopathy or contraindications to ocular injections (platelet count < 100,000/µL or INR > 1.5 unless corrected).
  • Pregnancy or breastfeeding.
  • Women of childbearing potential unwilling to use effective contraception during the study period.
  • Uncontrolled systemic disease that 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

  • Rubens Siqueira Research Center

    São José do Rio Preto, São Paulo, 15010-100

Other trials in Brazil

About this study

Official title: Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study

This prospective, comparative pilot study investigates the safety and functional outcomes of intravitreal adalimumab (ADA) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP).

Participants will receive three intravitreal injections of adalimumab (2 mg/0.05 mL) at two-month intervals (M0, M2, M4).

Read more

The primary objective is to assess functional changes after 6 months, focusing on visual-field preservation (Field Preservation Deviation Index - FPDI, Mean Deviation - MD) and best-corrected visual acuity (LogMAR).

Secondary outcomes include alterations in 30-Hz flicker ERG amplitude, OCT parameters (central macular thickness and ellipsoid zone length), and ocular safety measures such as intraocular pressure and inflammatory response.

Read the detailed description

Retinitis pigmentosa (RP) represents a genetically and phenotypically heterogeneous group of inherited retinal dystrophies characterized by progressive photoreceptor degeneration, classically beginning with rod dysfunction and followed by cone loss. Patients typically present with nyctalopia, peripheral visual-field constriction, and, in advanced stages, central vision impairment. Despite significant advances in gene-specific, cell-based, and prosthetic approaches, most patients currently lack broadly applicable interventions capable of slowing or reversing disease progression across RP's wide genotypic spectrum.

Recent evidence reframes RP as not only a genetic degenerative process but also a state of chronic para-inflammation in the outer retina. Microglial activation, breakdown of the blood-retinal barrier, and overexpression of pro-inflammatory cytokines-particularly tumor necrosis factor-alpha (TNF-α)-have been implicated in accelerating photoreceptor apoptosis and secondary cone degeneration. Within this biological context, adalimumab (ADA), a fully human monoclonal antibody that selectively inhibits TNF-α, offers a mechanism-based therapeutic rationale for mitigating inflammatory injury in RP.

This prospective, single-arm pilot study was designed to evaluate the functional impact and ocular safety of intravitreal adalimumab in patients with RP. Participants received three intravitreal ADA injections (2 mg/0.05 mL) at two-month intervals (M0, M2, M4). The primary assessments included best-corrected visual acuity (BCVA, LogMAR), visual-field metrics (FPDI, MD, PSD; using 10-2 for advanced and 24-2 for less advanced disease), and 30-Hz flicker ERG when measurable. Structural endpoints comprised OCT-derived central macular thickness and ellipsoid zone (EZ) length. Outcomes were analyzed for pre-post change over six months (M0-M6) and feasibility in a real-world clinical research setting.

This exploratory study aims to generate foundational data to guide future controlled trials of anti-TNF therapy in inherited retinal degenerations with inflammatory components.

Being tested
Intravitreal Adalimumab
Keywords
retinitis pigmentosa, intravitreal adalimumab, visual field, ERG, Ellipsoid zone, retinal degeneration
Medical subject headings
Retinitis Pigmentosa, Retinal Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal AdalimumabDrug

    Participants receive intravitreal injections of adalimumab 2 mg/0.05 mL at baseline (M0), month 2 (M2), and month 4 (M4).

Study groups in NCT07348588
Study groupRoleWhat they receive
intravitreal injection of adalimumabExperimentalParticipants receive intravitreal injections of adalimumab 2 mg/0.05 mL at baseline (M0), month 2 (M2), and month 4 (M4). This arm evaluates the effect of anti-TNF-α immunomodulation alone on visual function and retinal structure in patients with Retinitis Pigmentosa and EMAP.
Receives: Drug: Intravitreal Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted16 Jan 2026
  2. Study start10 Jul 2025
  3. Primary completion5 Feb 2026
  4. Study completion1 Aug 2027 (estimated)

Resources

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
his is a prospective, single-arm, open-label interventional pilot study designed to assess the ocular safety, feasibility, and functional outcomes of intravitreally administered adalimumab in patients with retinitis pigmentosa. All participants receive the same intervention-adalimumab 2 mg/0.05 mL-administered at baseline (M0), and at two-month intervals (M2, M4), for a total of three injections. Given the exploratory nature and rarity of the condition, no randomization or masking is applied. Each participant serves as their own control, with outcomes evaluated as within-subject pre-post changes from baseline to six months (M0-M6). The study is structured to provide proof-of-concept data regarding the therapeutic potential of local TNF-α inhibition in inherited retinal degenerations. This model prioritizes real-world applicability, tolerability, and early detection of functional trends (visual acuity, field sensitivity, ERG, and OCT biomarkers) to inform the design of future controlled
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07348588
Sponsor's protocol ID
ADARET
Acronym
ADARET
Status last verified
Oct 2026
First submitted
30 Nov 2025
Last updated
27 Oct 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. The Role of Cytokines in Degenerative Retinal Diseases: A Comprehensive Review. Biomedicines. 2025 Jul 15;13(7):1724. doi: 10.3390/biomedicines13071724.

    PubMed 40722794

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intravitreal Adalimumab in people with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy With Pseudodrusen (EMAP), run by Centro de Pesquisa Rubens 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 9 inclusion and 14 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 27 Oct 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 NCT07348588, 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 27 Oct 2026.

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