Diabetic related Macula edema
Conditions
Interventions
Trade Name: ILUVIEN 190 Mikrogramm
intravitreales Implantat im Applikator
Pharmaceutical Form: Intravitreal implant in applicator
INN or Proposed INN: F
Sponsors
J. W. Goethe University, represented by dean of the medical faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient has at least 18 years of age - Willingness and ability to give written informed consent - Fertile men and women of childbearing potential agree to use effective contraception (Pearl-Index =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Criteria concerning study eye: • Vitreous body completely removed (3-Port vitrectomy) • Previous pharmacological treatment with anti-angiogenic agent (e.g. Ranibizumab, Bevacizumab), cppV with drug treatment or prior laser coagulation within 90 days before screening • Previous pharmacological treatment with long-acting corticosteroids (periocular or intraocular) within 90 days before screening • Cataract surgery within 90 days before screening • Application of a yttrium-aluminium-garnet laser within 90 days before screening • Intraocular surgery within 90 days before screening • Ocular disease (e.g. inflammation, infection, virus-related disorders of cornea and conjunctiva) at screening • Clinical significant glaucoma General exclusion criteria: • The patient is pregnant or is nursing before and during study treatment • Contraindication for application of Iluvien® according to SmPC • Uncontrolled hypertension (RR > 160/90 mmHg) • Autoimmune disease • Poorly controlled diabetes mellitus (HbA1c < 10%) • Participation in other clinical trials within 30 days before screening • History of drug, alcohol, or chemical substances abuse within 180 days before screening • Any condition that is contradictory to a participation in this trial according to the investigator’s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The impact of Iluvien® therapy on the following factors will be investigated as secondary objectives: VEGF, IL-1b, IL-8, IP-10, ICAM-1, PDGF, MCP-1, PGF, PEDF ;Main Objective: The primary objective of this study is to investigate the impact of Iluvien® therapy on the inflammation factor IL-6 as both, IL-6 and growth factors, have a critical role in the development of DME. Later on and based on the results of this pilot study, the impact of Iluvien® therapy on the inflammation factor IL-6 will perhaps be analysed in a larger patient group treated over a longer period of time. ; Primary end point(s): The primary study endpoint is the determination of IL-6 concentration in the posterior vitreous at the following time points: - T0: Start of treatment (Iluvien® implantation) - T2: 1 month after Iluvien® implantation - T4: 6 month after Iluvien® implantation ;Timepoint(s) of evaluation of this end point: Evaluation of the end point can be performed after the last study visit (T4) has been completed and the last IL-6 concentration at T4 has been measured | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determination of concentrations of following factors: VEGF, IL-1b, IL-8, IP-10, ICAM-1, PDGF, MCP-1, PGF, PEDF concentration in the posterior vitreous at the following time points: - T0: Start of treatment (Iluvien® implantation) - T2: 1 month after Iluvien® implantation - T4: 6 month after Iluvien® implantation ;Timepoint(s) of evaluation of this end point: Evaluation of the end point can be performed after the last study visit (T4) has been completed and the last concentrations at T4 have been measured | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Frank Koch
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Klinik für Augenheilkunde
Outcome results
None listed