ImmunogenicityPhase 1NCT07429474

Safety and Immunogenicity of PRO-169 in Patients With Diabetic Macular Edema

A Phase 1 study testing PRO-169 in people with Immunogenicity and Anti-drug Antibodies (ADAs), run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Phase I, prospective, interventional, open-label, multicenter clinical trial to evaluate the safety of intravitreal PRO-169 through the presence of serum anti-drug antibodies (ADAs) to bevacizumab. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunogenicity, Anti-drug Antibodies (ADAs)
What is being tested?: PRO-169
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteMexico
Study dates: 1 Mar 2026to 15 Dec 2026
Phase: Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years.
Diagnosis of type 1 or type 2 diabetes.
Ability to provide signed informed consent.
Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
All subjects (male and female) who are biologically capable of having children must agree and commit to using a barrier or hormonal contraceptive method (by any route of administration) for the entire duration of the study and for 3 months after the last intravitreal injection.
Female subjects who are biologically capable of having children must have a negative urine pregnancy test at the screening visit.

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Best-corrected visual acuity (BCVA) according to the ETDRS chart from 24 to 78 letters (approximate Snellen equivalent of 20/32 to 20/320).
Diabetic macular edema with central involvement evidenced by spectral domain optical coherence tomography (central macular thickness criterion > 300 µm for men and > 290 µm for women) within 8 days prior to inclusion. All measurements taken on a subject must be taken with an instrument of the same make and model throughout the study.
Meet characteristics that allow for adequate fundus examination (media transparency, adequate pupil dilation).
Glycosylated hemoglobin < 12% from a result no older than 3 months.

Who cannot join

Chronic kidney disease with renal failure (glomerular filtration rate [eGFR] <15 mL/min/1.73 m2) requiring dialysis or transplantation; according to the 2020 Clinical Practice Guideline for the Management of Diabetes in Chronic Kidney Disease from the Kidney Disease Improving Global Outcomes (KDIGO) organization.
Active proliferative diabetic retinopathy in the study eye, including rubeosis iridis, vitreous hemorrhage, or tractional retinal detachment visible during the screening visit.
Individuals who have required initiation of insulin therapy for glycemic control within 4 months prior to the screening visit.
Previous participation in clinical studies with investigational products, ocular or systemic (at least 30 days must have elapsed between the end of participation in a previous trial and inclusion in this study).
Known hypersensitivity or allergy to bevacizumab or any ingredient in the investigational product.
Poorly controlled blood pressure (average of 3 blood pressure readings in a seated position with ≥160 mmHg systolic or ≥100 mmHg diastolic) at the screening visit.

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Myocardial infarction or other cardiovascular event (cerebrovascular disease, transient cerebral ischemia, or hospitalization for heart failure) during the 4 months prior to the screening visit, or subjects with active myocardial ischemia.
Systemic treatment with VEGF-related drugs within 4 months prior to the screening visit.
History of any rheumatological or collagen disease of autoimmune origin related to inflammatory processes such as: systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, Behçet's disease, dermatomyositis, among others.
History of any disease that causes immunosuppression or immunodepression, except diabetes mellitus.
Concomitant use of immunosuppressive agents, immunotherapy, or monoclonal antibodies by any route of administration (other than intravitreal) in the 2 years prior to the screening visit or during the study period.
Subjects who have received intravitreal anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, faricimab, brolucizumab) in the study eye within 4 months prior to the screening visit.
Use of intraocular or periocular corticosteroids in the study eye within 4 months prior to the screening visit, or use of intravitreal corticosteroid implants at any time.
Use of anticoagulants or antiplatelet agents by any route of administration within 10 days prior to the screening visit or during the study period.
Women of childbearing potential who are pregnant, breastfeeding, or planning to become pregnant during the study period.
Allergy to fluorescein (topical or intravenous) or to anesthetic medications used during the injection procedure.
Subjects with non-diabetic macular edema.
Lens opacities that, according to the LOCS III (Lens Opacities Classification System) classification, exceed one or more of the following criteria: nuclear component > NO3C3 (opalescence/color), cortical component > C2, and posterior subcapsular component > P1.
History of eye surgery (cataract extraction, any intraocular surgery, aphakia, etc.) or panretinal photocoagulation within 3 months prior to the screening visit or planned within the study period.
Intraocular pressure greater than 21 mmHg in the selected eye, measured by Goldmann tonometry at the screening visit.
Presence of macular ischemia or significant perifoveal capillary loss (increase in foveal avascular zone greater than 350 µm) demonstrated by fluorescein retinal angiography (during the screening visit or in a study performed within 4 months prior to the screening visit).
History of YAG capsulotomy in the study eye within 30 days prior to the screening visit.
Evidence of external eye infections, intraocular inflammation, or significant ocular surface disease in either eye within 30 days prior to the screening visit.
History of uveitis in the study eye.
History of retinal detachment, vitrectomy, any type of filtering surgery, corneal transplant, or corneal dystrophy in the selected eye.
Advanced glaucoma or optic neuropathy in the selected eye.
Having only one functional eye (best corrected visual acuity of finger counting or less in the eye with the worst vision).
Having previously participated in this same study.
Being or having an immediate family member (e.g., parent/legal guardian or sibling) who is part of the research site staff or sponsor.
Subjects with conditions that make it difficult or impossible to draw blood, such as veins that are difficult to see or feel, venous thrombosis in the area where the sample is taken, severe edema, or any other criteria determined by the personnel responsible for performing this procedure.
Difficulty interpreting the optotypes on the ETDRS chart.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alejandra Sanchez-Rios, MD contact

+52 33 3001 4200 ext. 1190

alejandra.sanchez@sophia.com.mx

Mexico1 site

Asociación para Evitar la Ceguera en México I.A.P
Coyoacán, Mexico City, 04030
Grecia Yael Ortiz Ramirez, MD

Other trials in Mexico

About this study

Official title: Phase I Clinical Trial to Evaluate Safety by Determining Immunogenicity Following Unilateral Intravitreal Administration of PRO-169 in Patients With Diabetic Macular Edema

Phase I, prospective, interventional, open-label, multicenter clinical trial to evaluate the safety of intravitreal PRO-169 through the presence of serum anti-drug antibodies (ADAs) to bevacizumab.

Conditions: Immunogenicity, Anti-drug Antibodies (ADAs)
Being tested: PRO-169

What participants receive

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

PRO-169Biological
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection.

Study groups in NCT07429474
Study group	Role	What they receive
PRO-169	Experimental	Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All participants included in the study will receive an injection of the investigational product every 30 days for two months (a total of 3 doses will be administered). Receives: Biological: PRO-169

What is being measured

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

Proportion of patients with positive serum ADAs for bevacizumab.
Positive results will be those where the baseline result shows no presence of ADAs (i.e., the result obtained in the blood sample for immunogenicity collected during the screening visit) and at least one sample shows the presence of ADAs after starting treatment with PRO-169.
Baseline result with the presence of ADAs and at least one sample with a result ≥ 4 times the baseline titers after initiation of treatment with PRO-169.
Measured: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

Secondary outcomes (7)

Incidence of adverse events related to the IP.
An adverse event is considered to be any adverse medical occurrence that happens to a patient or clinical research subject who has been administered a pharmaceutical product and where a causal relationship is at least reasonably possible.
Measured: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Incidence of serious adverse events related to the IP.
A serious adverse event is considered to be any event that results in: death, life-threatening, requires hospitalization or prolongs hospitalization, causes permanent or significant disability or incapacity, causes alterations or malformations in the newborn, or other medically important conditions.
Measured: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Total area under the curve (AUC) of PRO-169 serum concentration
The total amount of drug that reaches the systemic circulation. It is an important measure of bioavailability and relates variations in the serum concentration of a drug over time.
Measured: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Maximum serum concentration (Cmax) of PRO-169
Maximum serum concentration of the drug
Measured: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Maximum serum time (Tmax) of PRO-169
the time expressed in minutes that indicates the moment when the drug reaches its maximum concentration in serum
Measured: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Changes in best-corrected visual acuity (BCVA)
The ETDRS chart will be used to evaluate the subject's best refractive correction (obtained using an auto keratorefractometer and subjective tests) and the examination will be repeated using the refraction obtained. Comparing the changes obtained in the scheduled visits with respect to the baseline visit
Measured: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Changes in central macular thickness
This corresponds to the thickness determined in the fovea area, taking the fovea as the center point of a 1 mm circle. Comparing the changes obtained in the scheduled visits with respect to the baseline visit.
Measured: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202615 Dec 2026

First posted24 Feb 2026
Study start1 Mar 2026 (estimated)
Primary completion15 Dec 2026 (estimated)
Study completion15 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ImmunogenicityStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Phase I clinical trial, prospective, interventional, open-label, multicenter. In addition to the general safety variables of the study, pharmacokinetics will be evaluated in a cohort of 15 subjects.
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07429474
Sponsor's protocol ID: PRO-169-1224-I
Status last verified: Mar 2026
First submitted: 17 Feb 2026
Last updated: 13 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Alejandra Sanchez-Rios, MD

+52 33 3001 4200 ext. 1190

alejandra.sanchez@sophia.com.mx

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial to Evaluate Safety by Determining Immunogenicity Following Unilateral Intravitreal Administration of PRO-169 in Patients With Diabetic Macular Edema
ClinicalTrials.gov ID: NCT07429474
Acronym / sponsor ID: PRO-169-1224-I
Conditions: Immunogenicity, Anti-drug Antibodies (ADAs)
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
Study start: 1 Mar 2026 (estimated)
Primary completion: 15 Dec 2026 (estimated)
Study completion: 15 Dec 2026 (estimated)
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.

Phase I, prospective, interventional, open-label, multicenter clinical trial to evaluate the safety of intravitreal PRO-169 through the presence of serum anti-drug antibodies (ADAs) to bevacizumab.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Phase I clinical trial, prospective, interventional, open-label, multicenter. In addition to the general safety variables of the study, pharmacokinetics will be evaluated in a cohort of 15 subjects.

Arm	Type	Receives
PRO-169	Experimental	Biological: PRO-169Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All participants included in the study will receive an injection of the investigational product every 30 days for two months (a total of 3 doses will be administered).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥ 18 years.
Diagnosis of type 1 or type 2 diabetes.
Ability to provide signed informed consent.
Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
All subjects (male and female) who are biologically capable of having children must agree and commit to using a barrier or hormonal contraceptive method (by any route of administration) for the entire duration of the study and for 3 months after the last intravitreal injection.

Key exclusion criteria (31 listed)

Chronic kidney disease with renal failure (glomerular filtration rate [eGFR] <15 mL/min/1.73 m2) requiring dialysis or transplantation; according to the 2020 Clinical Practice Guideline for the Management of Diabetes in Chronic Kidney Disease from the Kidney Disease Improving Global Outcomes (KDIGO) organization.
Active proliferative diabetic retinopathy in the study eye, including rubeosis iridis, vitreous hemorrhage, or tractional retinal detachment visible during the screening visit.
Individuals who have required initiation of insulin therapy for glycemic control within 4 months prior to the screening visit.
Previous participation in clinical studies with investigational products, ocular or systemic (at least 30 days must have elapsed between the end of participation in a previous trial and inclusion in this study).
Known hypersensitivity or allergy to bevacizumab or any ingredient in the investigational product.

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
PRO-169Bevacizumab 1.25 mg / 0.05mL for intravitreal injection.	Biological	PRO-169

Primary outcome

Proportion of patients with positive serum ADAs for bevacizumab.
Time frame: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Positive results will be those where the baseline result shows no presence of ADAs (i.e., the result obtained in the blood sample for immunogenicity collected during the screening visit) and at least one sample shows the presence of ADAs after starting treatment with PRO-169. Baseline result with the presence of ADAs and at least one sample with a result ≥ 4 times the baseline titers after initiation of treatment with PRO-169.

7 secondary outcomes

Incidence of adverse events related to the IP.
Time frame: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Incidence of serious adverse events related to the IP.
Time frame: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Total area under the curve (AUC) of PRO-169 serum concentration
Time frame: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Maximum serum concentration (Cmax) of PRO-169
Time frame: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Maximum serum time (Tmax) of PRO-169
Time frame: Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Changes in best-corrected visual acuity (BCVA)
Time frame: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)
Changes in central macular thickness
Time frame: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

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 13 Mar 2026.
Individual participant dataSharing planned: No

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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.

Alejandra Sanchez-Rios, MD contact

+52 33 3001 4200 ext. 1190

alejandra.sanchez@sophia.com.mx

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRO-169 in people with Immunogenicity and Anti-drug Antibodies (ADAs), run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

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 10 inclusion and 31 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: opening soon, as of the sponsor's last update on 13 Mar 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 Mexico. 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 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.

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?

Contact Alejandra Sanchez-Rios, MD (+52 33 3001 4200 ext. 1190, alejandra.sanchez@sophia.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with positive serum ADAs for bevacizumab. (time frame: Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)). 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 NCT07429474.

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 13 Mar 2026.