Comparison of systemic VEGF levels after intravitreal ranibizumab versusaflibercept injections in patients with diabetic macular edema

Phase 1

• Conditions: Visual impairment due to diabetic macula edema; MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-001639-35-IT
• Lead Sponsor: OVARTIS PHARMA SERVICES AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-07-01
• Study Start: 2021-01-21
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

•Male or female patients, = 18 years of age.
•Written informed consent must be obtained before any assessment is
performed.
•Type 1 or Type 2 diabetes mellitus according to ADA (2014) and/or
WHO (2006) classifications (see Appendix 1, Table 13-2) with
glycosylated hemoglobin (HbA1c) = 10% (= 86 mmol/mol) at screening.
Patients should be on dietand/or exercise and/or pharmacological
treatment for diabetes, which must have been stable for at least 3
months.
•Visual impairment due to DME
• Patients with a baseline BCVA of 78 to 24 (20/32–20/320) ETDRS letters
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Systemic medical history and conditions
•Stroke less than 3 months prior to screening.
•Presence of uncontrolled systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening or baseline.
•Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening
Prior or current systemic medication:
•Use of any systemic anti-VEGF drugs (e.g., bevacizumab [Avastin®], ziv-aflibercept [Zaltrap®]) ithin 6 months prior to screening
•Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
•Use of any anti-coagulants agents within 3 months prior to screening
Prior or current ocular treatment or conditions:
For study eye:
•Panretinal laser photocoagulation within 6 months prior to randomization.
•Focal/grid laser photocoagulation within 3 months prior to randomization.
•Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
•Application of intravitreal corticosteroids (incl. corticosteroid releasing
implant, e.g. Ozurdex®) in vitreous within 6 months prior to screening.
Prior application of fluocinolone acetonide releasing implant (Iluvien®)
in vitreous within 36 months prior to screening.
For fellow eye
•Retinal or choroidal neovascularization or macula edema of any cause involving the fovea requiring anti-VEGF treatment at the time of screening or baseline or the anticipation of development of the above mentioned medical conditions requiring anti-VEGF treatment within 6 months past screening or baseline.
•History of treatment with any anti-angiogenic drugs (including any anti-VEGF agents, e.g., bevacizumab [Avastin®]) 6 months prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified