Cytokine Levels within patients with diabetic macular edema.

Aqueous Humor cytokine Levels following intravitreal ranibizumab or dexamethasone therapy in patients with diabetic macular edema

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005700-24-AT

Enrollment

Registered

2015-07-24

Start date

2015-08-17

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy and diabetic macular edema are leading causes for visual loss and blindness in young adults around the world. MedDRA version: 18.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Interventions

Trade Name: Lucentis Product Name: Lucentis Product Code: EMEA/H/C/000715 Pharmaceutical Form: Injection INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Current Sponsor code: RFB002 Other des

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinically significant diabetic macular edema (DME), no treatment 3 months prior to study inclusion - Age 18 and older - Informed consent of the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Therapeutic treatment within the last 3 months prior to study inclusion - Retinal diseases: o Epiretinal membrane o Vitreomacular traction syndrome o Retinal atrophy (definition of degenerative edema according to the SAVE grading protocol) - Any other retinal disease than diabetic retinopathy and/or diabetic macular edema - Glaucoma - Ocular or periocular infections - Torn or ruptured posterior lens capsule in phakic patients - Hypersensitivity to any components of the two products - Fluorescein allergy and history of severe reactions - Women of childbearing age - Dementia; inability to follow commands

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate new insights into molecular pathways following anti-VEGF and corticosteroid intravitreal injections and their relationship to intravitreal cytokine concentration. ;Secondary Objective: To investigate new insights into molecular pathways following anti-VEGF and corticosteroid intravitreal injections and their relationship to the changes in retinal morphology and function.;Primary end point(s): 1) Change in aqueous humour cytokine Levels ;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed after week 2, week 4, week 8, week 12, week 16 and week 20	—

Measure

Time frame

Main Objective: To investigate new insights into molecular pathways following anti-VEGF and corticosteroid intravitreal injections and their relationship to intravitreal cytokine concentration. ;Secondary Objective: To investigate new insights into molecular pathways following anti-VEGF and corticosteroid intravitreal injections and their relationship to the changes in retinal morphology and function.;Primary end point(s): 1) Change in aqueous humour cytokine Levels ;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed after week 2, week 4, week 8, week 12, week 16 and week 20

—

Secondary

Measure	Time frame
Secondary end point(s): 2) Changes in retinal morphology and function ;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed after week 2, week 4, week 8, week 12, week 16 and week 20	—

Countries

Austria

Contacts

Public ContactOphthalmologist

Abteilung für Augenheilkunde, AKH Linz

matthias.bolz@akh.linz.at004373278061050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026