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CompletedNCT05217680PRO-169Updated Sep 22, 2026Results posted

Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

A Phase 3 interventional study of Bevacizumab and Lucentis® in Diabetic Macular Edema, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Laboratorios Sophia S.A de C.V. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
509
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Phase III clinical study to evaluate the efficacy, expressed as improvement in visual acuity in patients suffering diabetic macular edema after one year of treatment with PRO-169, compared to treatment with Lucentis® (ranibizumab).

Read the detailed description

A total of 442 patients with diabetic macular edema will be randomized 1:1 to be treated with either PRO-169 (bevacizumab) or Lucentis® (ranibizumab). There will be a total of 14 visits, including selection and final visits. Monthly evaluations will include ophthalmologic evaluations of anterior and posterior segments, as well as OCT (optic coherence tomography) to obtain central macular width and retinal volume. Fluorescein angiography will be performed on selection visit as well as 6 and 12 months into the study (visits 7 and 13). All patients will be exposed to intravitreal injection of either of the studied drugs monthly for the first 4 months. Starting on visit 5 patients will be injected depending on their response to treatment, calculated according predetermined algorithms including clinical and image variables. Starting on month 6, patients may be subjected to rescue therapy with photocoagulation if they comply with predetermined criteria for such measure.

02

Conditions studied

  • Diabetic Macular Edema
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of Diabetes Mellitus (type 1 or 2) evidenced by: use of insulin or use of oral hypoglycemic medications or diagnosis for DM according to OMS or ADA criteria.
  • Is capable of rendering informed consent.
  • HbA1c \<9.5% in selection visit.
  • All men and women capable of reproduction may agree to use a barrier birth control method during the study and 3 months after the last intravitreal injection applied.
  • Only one eye may be randomized per participating individual, in case both are eligible, the investigator may choose either eye according his/her criteria.
  • BVCA according to ETDRS between \<78 (20/32 or worse) and >24 (20/320 or better) within 8 days prior to the randomization.
  • Clinically evident diabetic macular edema, with central macular thickening.
  • Diabetic macular edema demonstrated in OCT scan (macular central thickness > 300 μm for men and > 290 μm for women) within 8 days prior to the randomization.
  • Presenting characteristics that allow an adequate fundus examination (transparent means, adequate pupil dilation, etc).

Exclusion criteria

Exclusion Criteria:

  • Chronic renal disease with renal insufficiency that requires dialysis or transplant.
  • Individuals with conditions that may compromise their participation during the span of the study (unstable concomitant diseases, possible change of residence, etc)
  • Individuals with a poor glycemic control who have started insulin treatment within 4 months previous to the study.
  • Participation in another clinical study (at least 90 days must have elapsed between the finalization of his/her participation in a previous essay and randomization in the present study).
  • Known allergies to the treatment.
  • Poorly controlled blood pressure (average of 3 readings while sitting with ≥160 mmHg systolic or ≥100 mmHg diastolic in the selection visit.
  • Heart attack or other cardiovascular event (cerebral vascular disease, transitory ischemia, hospitalization for cardiac insufficiency) during the 4 months prior to the start of the study, or patients with active myocardial insufficiency.
  • Previous systemic treatment with VEGF-related medications within 4 months prior to the start of the study.
  • Women of child-bearing age who are pregnant, lactating of planning to get pregnant within the time span of the study.
  • Known allergy to anesthetic medications used during the procedures, intravitreal injection and photocoagulation.
  • Diagnosis of non-diabetic macular edema.
  • Ophthalmic conditions that interfere with the evaluation of BCVA (for example: foveal atrophy, pigmentary abnormalities, dense foveal exudates, etc)
  • Additional conditions to DM that may compromise the evaluation of the edema (for example: venous occlusions, uveitis or other inflammatory diseases, neovascular glaucoma, etc)
  • Lens opacities that according to the LOCS III classification system exceed one or more of the following: > NO3C3, > C2, > P1.
  • Previous history of anti-VEGF treatment for diabetic macular edema or any treatment for diabetic macular edema within 4 months prior to the start of the study (corticosteroids, photocoagulation, etc)
  • Anticipation of the need of panphotocoagulation (for example: proliferative diabetic retinopathy or any other indication) during the period of the study or history of panphotocoagulation within the 4 months prior to the start of the study.
  • History of ocular surgery (cataract extraction, any intraocular surgery, aphakia, etc) within 4 months prior to the start of the study, or planned to occur within the time span of the study.
  • Intraocular pressure > 21 mmHg, measured through Goldmann tonometry during the selection visit.
  • Presence of macular ischemia or important loss of perifoveal capilaries (avascular foveal zone greater than 350 μm) demonstrated through fluorescein angiography during the selection visit.
  • Evidence of macular traction and hyaloid thickening in OCT scan.
  • History of YAG capsulotomy within 2 months prior to the randomization.
  • Evidence of external ocular infections or any important disease of the ocular surface.
  • History of vitrectomy.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
509 participants (actual)

Study arms

  • Experimental
    PRO-169

    Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.

    Biological: Bevacizumab

  • Active comparator
    Lucentis ®

    Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.

    Biological: Lucentis®

Interventions

  • BiologicalBevacizumab

    Administration of monthly intravitreal bevacizumab (4-12 injections)

  • BiologicalLucentis®

    Administration of monthly intravitreal ranibizumab (4-12 injections)

05

What researchers measure

Primary outcomes

  1. Best Corrected Visual Acuity

    Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

    Time frame: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)

Secondary outcomes

  1. Best Corrected Visual Acuity Area Under the Curve

    Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The area under the curve of both treatments will be used evaluated as difference between baseline and final (12 months) values.

    Time frame: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)

  2. Best Corrected Visual Acuity

    Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The corrected BCVA (adjusted to baseline value) of both treatments will be used evaluated at 4 months. The value was obtained from the value obtained on day 120 minus the baseline value.

    Time frame: Day 120±3 (Visit 5)

  3. Central Macular Thickness

    Central macular thickness will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

    Time frame: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)

  4. Retinal Volume

    Retinal volume will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

    Time frame: Day 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)

  5. Percentage of Patients With a Positive Response to Treatment.

    Determining the percentage of patients with a positive response to treatment, considered as: absolute improvement (20/20 vision for two consecutive visits and central macular thickness \< 300 μm in men and \< 290 μm in women), improvement (one or more of the following: patient who gained 5 or more letters for BCVA, ≥ 10% decrease of macular central thickness value compared to last two visits) and stability (one or more of the following: patient with neither a gain of 5 or more letters for BCVA nor a ≥ 10% decrease of macular central thickness value compared to last two visits, patient without loss of 5 or more letters for BCVA or a ≥ 10% decrease of macular central thickness value compared to last visit).

    Time frame: Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)

  6. Mean Number of Injections

    Determining the mean number of injections applied during study, comparing both arms.

    Time frame: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)

  7. Frequency of Rescue Therapy Administration

    Number of patients who required photocoagulation treatment

    Time frame: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)

  8. Adverse Events Related to the Injection

    This section describes the treatment-related adverse events reported throughout the study

    Time frame: Day 360±3 (Final Visit)

  9. Ophthalmic Drug-related Adverse Events

    The number of adverse events related to the eyes associated with the medication is described.

    Time frame: Day 360±3 (Final Visit)

  10. Systemic Drug-related Adverse Events

    The number of treatment-related adverse events at the systemic level is described

    Time frame: Day 360±3 (Final Visit)

06

Results

Posted May 26, 2026

Participant flow

Participant flow — Overall Study
MilestonePRO-169Lucentis ®
Started255254
Population by intention to treat (itt)204201
Completed186189
Not completed6965

Outcome measures

PrimaryBest Corrected Visual Acuity

Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

Time frame:
Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Reported as:
Mean · Letters
Best Corrected Visual Acuity
LettersPRO-169Lucentis ®
Visit 24.89 ± 7.45.55 ± 8.5
Visit 37.09 ± 8.17.71 ± 9.6
Visit 47.90 ± 8.88.65 ± 10.0
Visit 58.68 ± 8.79.92 ± 10.3
Visit 68.99 ± 9.010.70 ± 10.5
Visit 78.89 ± 8.811.15 ± 10.9
Visit 89.38 ± 9.611.23 ± 10.9
Visit 99.43 ± 9.611.68 ± 10.6
Visit 109.43 ± 9.312.01 ± 10.9
Visit 119.91 ± 9.312.29 ± 11.1
Visit 1210.26 ± 10.012.71 ± 11.4
Visit 1310.44 ± 10.412.54 ± 11.5
Statistical analysis
  • PRO-169 vs Lucentis ® · Wilcoxon (Mann-Whitney) · p = <0.05 (The p-value was not taken into account for the determination of non-inferiority.) · Mean difference (final values): -1.5
SecondaryBest Corrected Visual Acuity Area Under the Curve

Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The area under the curve of both treatments will be used evaluated as difference between baseline and final (12 months) values.

Time frame:
Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Reported as:
Mean · Letters*day
Best Corrected Visual Acuity Area Under the Curve
Letters*dayPRO-169Lucentis ®
Visit 22.50 ± 3.72.82 ± 4.4
Visit 34.27 ± 5.44.76 ± 6.6
Visit 45.35 ± 6.15.92 ± 7.5
Visit 56.10 ± 6.56.66 ± 8.0
Visit 66.65 ± 6.77.50 ± 8.3
Visit 77.04 ± 6.98.09 ± 8.6
Visit 87.34 ± 7.18.54 ± 8.8
Visit 97.60 ± 7.28.92 ± 8.9
Visit 107.94 ± 7.39.25 ± 9.0
Visit 117.98 ± 7.49.55 ± 9.1
Visit 128.17 ± 7.49.82 ± 9.2
Visit 138.36 ± 7.410.05 ± 9.3
SecondaryBest Corrected Visual Acuity

Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The corrected BCVA (adjusted to baseline value) of both treatments will be used evaluated at 4 months. The value was obtained from the value obtained on day 120 minus the baseline value.

Time frame:
Day 120±3 (Visit 5)
Reported as:
Mean · Letters
Best Corrected Visual Acuity
LettersPRO-169Lucentis ®
Best Corrected Visual Acuity8.70 ± 8.69.98 ± 10.5
SecondaryCentral Macular Thickness

Central macular thickness will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

Time frame:
Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Reported as:
Mean · μm
Central Macular Thickness
μmPRO-169Lucentis ®
Visit 2-74.43 ± 105.1-94.69 ± 102.7
Visit 3-83.58 ± 110.3-115.79 ± 100.5
Visit 4-96.24 ± 112.7-129.63 ± 109.6
Visit 5-98.12 ± 113.0-135.21 ± 109.9
Visit 6-95.40 ± 115.1-140.65 ± 115.4
Visit 7-97.70 ± 117.1-141.84 ± 113.0
Visit 8-92.59 ± 118.9-134.82 ± 122.3
Visit 9-97.55 ± 109.5-139.10 ± 113.1
Visit 10-106.54 ± 115.7-141.55 ± 115.1
Visit 11-105.67 ± 121.5-146.25 ± 118.3
Visit 12-104.94 ± 123.9-147.35 ± 123.6
Visit 13-102.36 ± 129.4-144.10 ± 113.0
SecondaryRetinal Volume

Retinal volume will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

Time frame:
Day 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)
Reported as:
Mean · mm^3
Retinal Volume
mm^3PRO-169Lucentis ®
Visit 2-0.84 ± 1.3-1.06 ± 1.26
Visit 3-1.00 ± 1.3-1.26 ± 1.2
Visit 4-1.12 ± 1.3-1.57 ± 1.5
Visit 5-1.23 ± 1.5-1.67 ± 1.4
Visit 6-1.32 ± 1.5-1.77 ± 1.4
Visit 7-1.32 ± 1.5-1.82 ± 1.4
Visit 8-1.34 ± 1.6-1.72 ± 1.4
Vist 9-1.40 ± 1.6-1.79 ± 1.4
Visit 10-1.46 ± 1.6-1.84 ± 1.4
Visit 11-1.51 ± 1.6-1.93 ± 1.5
Visit 12-1.60 ± 1.7-1.88 ± 1.5
Visit 13-1.49 ± 1.7-1.87 ± 1.5
SecondaryPercentage of Patients With a Positive Response to Treatment.

Determining the percentage of patients with a positive response to treatment, considered as: absolute improvement (20/20 vision for two consecutive visits and central macular thickness \< 300 μm in men and \< 290 μm in women), improvement (one or more of the following: patient who gained 5 or more letters for BCVA, ≥ 10% decrease of macular central thickness value compared to last two visits) and stability (one or more of the following: patient with neither a gain of 5 or more letters for BCVA nor a ≥ 10% decrease of macular central thickness value compared to last two visits, patient without loss of 5 or more letters for BCVA or a ≥ 10% decrease of macular central thickness value compared to last visit).

Time frame:
Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Reported as:
Count of participants · Participants
Percentage of Patients With a Positive Response to Treatment.
ParticipantsPRO-169Lucentis ®
Visit 5 — Absolute improvement512
Visit 5 — Improvement8898
Visit 5 — Stability6558
Visit 5 — Other2821
Visit 6 — Absolute improvement616
Visit 6 — Improvement7680
Visit 6 — Stability6668
Visit 6 — Other3825
Visit 7 — Absolute improvement816
Visit 7 — Improvement6969
Visit 7 — Stability6873
Visit 7 — Other4131
Visit 8 — Absolute improvement1018
Visit 8 — Improvement6767
Visit 8 — Stability6564
Visit 8 — Other4440
Visit 9 — Absolute improvement915
Visit 9 — Improvement7571
Visit 9 — Stability5367
Visit 9 — Other4936
Visit 10 — Absolute improvement814
Visit 10 — Improvement7779
Visit 10 — Stability6261
Visit 10 — Other3935
Visit 11 — Absolute improvement914
Visit 11 — Improvement7579
Visit 11 — Stability6366
Visit 11 — Other3930
Visit 12 — Absolute improvement1020
Visit 12 — Improvement7564
Visit 12 — Stability7368
Visit 12 — Other2837
Visit 13 — Absolute improvement1117
Visit 13 — Improvement7261
Visit 13 — Stability6375
Visit 13 — Other4036
SecondaryMean Number of Injections

Determining the mean number of injections applied during study, comparing both arms.

Time frame:
Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Reported as:
Mean · injection
Mean Number of Injections
injectionPRO-169Lucentis ®
Mean Number of Injections9.56 ± 1.89.21 ± 2.2
SecondaryFrequency of Rescue Therapy Administration

Number of patients who required photocoagulation treatment

Time frame:
Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Reported as:
Count of participants · Participants
Frequency of Rescue Therapy Administration
ParticipantsPRO-169Lucentis ®
Frequency of Rescue Therapy Administration80
SecondaryAdverse Events Related to the Injection

This section describes the treatment-related adverse events reported throughout the study

Time frame:
Day 360±3 (Final Visit)
Reported as:
Number · number of events
Adverse Events Related to the Injection
number of eventsPRO-169Lucentis ®
Adverse Events Related to the Injection2429
SecondaryOphthalmic Drug-related Adverse Events

The number of adverse events related to the eyes associated with the medication is described.

Time frame:
Day 360±3 (Final Visit)
Reported as:
Number · number of events
Ophthalmic Drug-related Adverse Events
number of eventsPRO-169Lucentis ®
Ophthalmic Drug-related Adverse Events94
SecondarySystemic Drug-related Adverse Events

The number of treatment-related adverse events at the systemic level is described

Time frame:
Day 360±3 (Final Visit)
Reported as:
Number · number of events
Systemic Drug-related Adverse Events
number of eventsPRO-169Lucentis ®
Systemic Drug-related Adverse Events00

Adverse events

Collected over Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PRO-1692/255 (0.8%)2/255 (0.8%)114/255 (44.7%)
Lucentis ®3/254 (1.2%)3/254 (1.2%)103/254 (40.6%)
Most frequent serious events
Most frequent serious events
EventPRO-169Lucentis ®
StrokeNervous system disorders0/2551/254
Obstructive pancreatitisGastrointestinal disorders0/2551/254
OtherGastrointestinal disorders0/2551/254
Acute myocardial infarctionCardiac disorders1/2550/254
Urinary tract infection Septic shockInfections and infestations1/2550/254
Most frequent other events
Showing 10 of 168
Most frequent other events
EventPRO-169Lucentis ®
Eye irritationEye disorders16/25519/254
Conjunctival hemorrhageEye disorders6/25512/254
Eye discomfortEye disorders7/25512/254
HypertensionVascular disorders4/2559/254
Vitreous hemorrhageEye disorders8/2554/254
Pain at the injection siteGeneral disorders7/2557/254
Urinary tract infectionInfections and infestations5/2556/254
Ocular hypertensionEye disorders6/2553/254
CataractEye disorders3/2555/254
Diabetic footSkin and subcutaneous tissue disorders5/2552/254

Baseline characteristics

Demographic and baseline characteristics were analyzed in the intention-to-treat population (ITT)

Age, Continuous
Age, Continuous(years)PRO-169Lucentis ®Total
Mean62.65 ± 7.461.13 ± 8.561.90 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)PRO-169Lucentis ®Total
Female10196197
Male103105208
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)PRO-169Lucentis ®Total
Count of participants——0
HbA1c [%]
HbA1c [%](percentage of HbA1c)PRO-169Lucentis ®Total
Mean7.28 ± 0.97.30 ± 2.07.29 ± 1.0
BMI
BMI(kg/m^2)PRO-169Lucentis ®Total
Mean28.15 ± 4.527.14 ± 4.327.65 ± 4.4
Waist circumference
Waist circumference(centimeters)PRO-169Lucentis ®Total
Mean94.29 ± 14.592.47 ± 13.593.39 ± 14.93
Diabetes mellitus
Diabetes mellitus(years)PRO-169Lucentis ®Total
Mean16.75 ± 8.316.15 ± 8.916.45 ± 8.6
Diabetic macular edema
Diabetic macular edema(years)PRO-169Lucentis ®Total
Mean1.07 ± 1.51.20 ± 1.51.14 ± 1.5

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • SalaUno Salud, S.A.P.I. de C.V.
    Mexico City, Mexico City 06030, Mexico
08

References and documents

Publications

  • Salcedo-Villanueva G, Garcia-Sanchez G, Palacio-Pastrana C, Gascon-Guzman G, Moreno-Andrade A, Olvera-Montano O, Munoz-Villegas P. One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population. Int J Retina Vitreous. 2025 Aug 1;11(1):89. doi: 10.1186/s40942-025-00719-9. PubMed 40750915 ↗
  • Torres-Arellano JM, Tornero-Jimenez A, Sanchez-Rios A, Olvera-Montano O, Munoz-Villegas P. Evaluation of the Relationship Between Diabetic Macular Edema and Renal Function in a Latino Population. Ophthalmol Ther. 2023 Oct;12(5):2745-2755. doi: 10.1007/s40123-023-00787-w. Epub 2023 Aug 6. PubMed 37543959 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 17, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05217680
Lead sponsor
Laboratorios Sophia S.A de C.V.
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
May 24, 2021
Primary completion
Aug 18, 2025
Completion
Nov 25, 2025
Results posted
May 26, 2026
Last update
Sep 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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