ASSESSMENT OF THE EFFICACY OF SUBTENON NATURAL LEUCOCYTIC INTERFERON-a? (IFNa) FOR THE TREATMENT OF DIABETIC MACULAR EDEMA (DME): A PILOT STUDY.

ASSESSMENT OF THE EFFICACY OF SUBTENON NATURAL LEUCOCYTIC INTERFERON-a? (IFNa) FOR THE TREATMENT OF DIABETIC MACULAR EDEMA (DME): A PILOT STUDY. - OFT-Campos01-12

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002635-28-IT

Enrollment

Registered

2013-01-11

Start date

2013-04-19

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

DIABETIC MACULAR EDEMA (DME) MedDRA version: 14.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Interventions

Trade Name: ALFAFERONE*1F 1000000UI 1ML Pharmaceutical Form: Solution for injection INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA Concentration unit: IU international unit(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients affected by diabetes mellitus type II • DME documented by OCT examination (diffuse macular edema, cystoid macular edema, retinal serous detachment) with central foveal thickness > 300µm • Best corrected visual acuity from 2/10 to 6/10 • Age > 18 years old • Glycated hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: • Macular laser treatments in the previous 12 months. • Anti-VEGF or steroid intravitreal treatment in the previous 3 months. • Tractional diabetic macular edema • Proliferative diabetic retinopathy and/or vitreous hemorrhage. • Cataract surgery in the previous 6 months. • Any other ocular surgery in the previous 2 years. • Any other concomitant ocular disease, except for diabetic retinopathy. • Systemic steroid therapy • Systemic or topic interferon therapy • Pregnant or breastfeeding women • Known or suspected hypersensitivity to the experimental drug or to other drugs belonging to the pharmacologic class of the INF. • Severe clinical conditions that, in the opinion of the investigator, could preclude the patient’s enrollment to the study. • Any other experimental systemic drugs in the previous 6 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of IFN on DME, by measuring central foveal thickness (CFT).;Secondary Objective: To evaluate the effect of IFN on visual acuity (VA). To evaluate the maximum time lenght of the effect of IFN, during which further treatment are not necessary. To evaluate the safety and tolerability of subtenon IFN;Primary end point(s): To evaluate the effect of IFN on DME, by measuring central foveal thickness (CFT).;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate the effect of IFN on DME, by measuring central foveal thickness (CFT).;Secondary Objective: To evaluate the effect of IFN on visual acuity (VA). To evaluate the maximum time lenght of the effect of IFN, during which further treatment are not necessary. To evaluate the safety and tolerability of subtenon IFN;Primary end point(s): To evaluate the effect of IFN on DME, by measuring central foveal thickness (CFT).;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate the effect of IFN on visual acuity (VA). To evaluate the maximum time lenght of the effect of IFN, during which further treatment are not necessary. To evaluate the safety and tolerability of subtenon IFN;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Italy

Contacts

Public ContactU.O.Oftalmologia(Campos)DrM.Cellini

AOU di Bologna, Policlinico S.Orsola-Malpighi

mauro.cellini@unibo.it051/6362831

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026