Status:
RECRUITING
Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 treatmen...
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 sel...
Eligibility Criteria
Inclusion
- 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 \<8.5% 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
- 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.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT05217680
Start Date
May 17 2021
End Date
August 31 2025
Last Update
March 4 2025
Active Locations (2)
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1
Fundación Oftalmológica Nacional
Bogotá, Colombia
2
SalaUno Salud, S.A.P.I. de C.V.
Mexico City, Mexico, 06030