Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema (PRO-169)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    442
  • sponsor
    Laboratorios Sophia S.A de C.V.
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Updated on 7 October 2022
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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).

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.

Details
Condition Diabetic Macular Edema
Treatment bevacizumab, Lucentis®
Clinical Study IdentifierNCT05217680
SponsorLaboratorios Sophia S.A de C.V.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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 <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 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
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