E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary rhegmatogenous retinal detachment (RRD) accompanied by elevated protein levels in anterior chamber fluid (laser flare value ≥15pc/ms). |
|
E.1.1.1 | Medical condition in easily understood language |
Primary retinal detachment caused by retinal tear(s) combined with subclinical inflammatory conditions in the eye measured by laser flare photometry (laser flare value ≥15pc/ms)
|
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To reduce the incidence of PVR in high-risk patients (elevated protein levels in the anterior chamber fluid, laser-flare value ≥ 15 photon counts per millisecond (pc/ms)) with primary rhegmatogenous retinal detachment (RRD) by intraoperative adjuvant therapy with 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH). |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective is to investigate if adjuvant intravitreal therapy with 5-FU and LMWH effects postoperative outcome parameters and postoperative course in high risk patients with RRD |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Primary rhegmatogenous retinal detachment (< 4 weeks) in study eye 2. Scheduled for pars plana vitrectomy for retinal detachment repair without combined cataract surgery 3. Elevated protein levels in anterior chamber fluid (laser-flare value ≥ 15 pc/ms) in study eye 4. Male and female patients ≥ 18 years of age 5. Written informed consent
|
|
E.4 | Principal exclusion criteria |
1. Traumatic retinal detachment in study eye 2. Giant retinal tears in study eye (in size > 3 clock hours) 3. Visible pre-existing PVR grade C in study eye 4. Retinal dystrophies in study eye 5. Chronic inflammatory conditions in study eye 6. Active retinal vascular disease in study eye 7. Previous intraocular surgery except cataract surgery in study eye 8. Uncontrolled glaucoma or ocular hypertension in study eye (intraocular pressure ≥ 30 mmHg despite IOP lowering therapy) 9. Positive urine pregnancy test, pregnancy or breastfeeding mother.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
PVR grade CP 1 or higher [yes/no] within 12 weeks |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• PVR grade CP 1 or higher [yes/no] within 6 weeks • PVR grade CA 1 or higher [yes/no] within 6 weeks and 12 weeks • Degree of PVR (PVR grade CA 1-12, PVR grade CP 1-12 (in clock hours)) within 6 weeks and 12 weeks • Best corrected Visual Acuity (BCVA) measured by ETDRS charts within 6 weeks and 12 weeks • Retinal reattachment after primary intervention [yes/no] within 6 weeks and 12 weeks • Number of retinal re-detachments and if present due to PVR [yes/no] within 6 weeks and 12 weeks • Number and extent of surgical procedures necessary to achieve retinal reattachment within 12 weeks • Occurrence of at least one drug-related adverse event that affects the study eye [yes/no] within 12 weeks
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 18 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the clinical trial is defined as the last visit of the last patient (also end of study, EOS). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |