E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pseudophakic macular edema |
Pseudophakes Makulaödem |
|
E.1.1.1 | Medical condition in easily understood language |
Swelling of the retina caused by an accumulation of fluid following cataract (clouding of the eye lens) surgery |
Durch eine Flüssigkeitsansammlung hervorgerufene Schwellung der Netzhaut in Folge einer Katarakt (Linsentrübung: Grauer Star) Operation. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
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 assess the efficacy of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in subjects with pseudophakic cystoid macular edema, compared to a “watch-and-wait” strategy. |
Evaluierung der Wirksamkeit von Ketorolac-Trometamol Augentropfen oder einer Sub-Tenon-Injektion von Triamcinolonacetonid bei der Behandlung eines zystoiden Makulaödems, verglichen mit einer Observanzgruppe. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety of topical ketorolac tromethamine or a subtenon triamcinolone acetonide injection in this population, compared to a "watch and wait" strategy |
Evaluierung der Sicherheit von Ketorolac Trometamol Augentropfen bzw. einer Injektion von Triamcinolonacetonid bei dieser Patientengruppe, verglichen mit einer Observanzgruppe |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- ≥18 years of age
-Pseudophakia in the study eye
-No history of previous treatment of PME
-Signed written informed consent
-Cataract surgery ≤4 months in study eye
-BCVA ≥20/125; BVCA ≤20/32
-Presence of PME determined by fundus examination
-Presence of central macular edema determined by OCT
-No sign of significant diabetic retinopathy and/or maculopathy
|
- Alter ≥18
- Pseudophakie am Studienauge
- Keine vorangegangene Behandlung eines Makulaödems
- Unterschriebene Einwilligungserklärung
- Kataraktoperation längstens vier Monate vor Einschluss
- BCVA ≥20/125; BVCA ≤20/32
- Durch Fundusuntersuchung bzw. OCT Messung nachgewiesenes Makulaödem
- Keine signifikanten Makulopathien/diabetische Retinopathie |
|
E.4 | Principal exclusion criteria |
-Pregnancy /Breast-feeding
-Systemic treatment with corticosteroids in the preceding 14 days
-Systemic treatment with NSAIDs in the preceding 14 days
-Presence of any contradictions indicated in the summary of product characteristics for the use of topical ketorolac tromethamine 0.5% and subtenon triamcinolone acetonide injection
-Active choroidal neovascularization
-Retinal detachment
-Vitreoretinal surgery in the preceding year
-Myopia ≥8 diopters
-Uncontrolled glaucoma |
-Schwangerschaft/Stillen
-Systemische Kortikosteroid Behandlung innerhalb der vorangegangenen 14 Tage
- Sytemische Behandlung mit NSAIDs innerhalb der vorangegangenen 14 Tage
-Vorliegen von Kontraindikationen für die Behandlung mit der Studienmedikation
- Choroidale Neovaskularisationen
-Ablatio Retinae
-Vitreoretinale Operation im vorangegangenen Jahr
- Myopie ≥8 Dioptrien
- unkontrolliertes Glaukom |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in central retinal thickness measured by OCT from baseline to week 6 |
Mit OCT gemessene zentrale Netzhautdicke 6 Wochen nach Baseline
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 weeks after baseline |
6 Wochen nach Baseline |
|
E.5.2 | Secondary end point(s) |
-Change in BCVA (Best Corrected Visual Acuity) in ETDRS letters from baseline to week 3 and week 6
-Change in central retinal thickness measured by OCT from baseline to week 3
-Complete resolution (binary) of macular edema measured by OCT at week 3 and week 6
-Change in ocular pain assessment from baseline to week 3 and week 6
-Change in dry eye questionnaire from baseline to week 3 and week 6
|
-Veränderung der BCVA 3 und 6 Wochen nach Baseline
-Veränderung der mit OCT gemessenen zentralen Netzhautdicke 3 Wochen nach Baseline
-Resolution des Makulaödems nach 3 bzw. 6 Wochen
-Schmerzerhebung 3 und 6 Wochen nach Baseline
-Fragebogen Trockenes Auge 3 und 6 Wochen nach Baseline |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Three and six weeks after baseline |
Drei und 6 Wochen nach Baseline |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Observanzgruppe ohne Behandlung |
Watch and wait strategy: no treatment |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 2 |
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 | No |
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
|
LVLS |
Letzter Besuch des letzten Patienten |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |