E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Retinopathy and diabetic macular edema are leading causes for visual loss and blindness in young adults around the world. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057934 |
E.1.2 | Term | Diabetic macular edema |
E.1.2 | System Organ Class | 100000004853 |
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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 |
The aim of this study is to describe the outcome of a Treat and Extend regimen with aflibercept (Eylea) in patients with diabetic macular edema (DME). The main idea behind this treatment paradigm is to individualize the intervals of the intravitreal injections that have to be administered on a more or less regular basis. These adapted intervals are an approach to provide each DME patient with an individualized therapy regimen. |
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E.2.2 | Secondary objectives of the trial |
Furthermore, this study is designed to describe a possible disease management program for this indication by defining the work flow and the best point of service for each single examination and treatment and the interfaces between practitioner’s offices and a specialized center. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Men or post-menopausal women
-Presence of clinically significant diabetic macular edema with central involvement, as determined by fundoscopy, optical coherence tomography and /or fluorescence angiography
-Diabetes mellitus Typ I or Typ II
-No treatment of diabetic macular edema of any kind within 3 months prior to inclusion
-No other reason for macular edema or visual impairment except ametropia
-Willingness and able to comply with clinic visits and study-related procedures
-Proved a signed informed consent form
-If both eyes show signs of center involving swelling secondary to DME, the eye with worse visual acuity will be included in the study.
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E.4 | Principal exclusion criteria |
- Inability to communicate in German or English
- Dementia; inability to follow commands
- Untreated Epilepsy
- Neoplastic disease
- Active intraocular inflammation (grade trace or above) in the study eye.
- Active or suspected ocular or periocular infection in the study eye.
- Allergy to fluorescein
- Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
- Intraocular pressure > 30mm HG at screening
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E.5 End points |
E.5.1 | Primary end point(s) |
1) The visual acuity that can be achieved,
2) the mean number of visits performed at the practitioner’s office and
3) the mean number of injections. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be after 2 years, an interim analysis is planned after 1 year. |
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E.5.2 | Secondary end point(s) |
1) Retinal Morphology assessed by OCT and FA at year 1, 2 and 3
2) Visual acuity at year 1 and 3
3) Quality of Life at year 1, 2 and 3
4) the mean extension of the treatment intervals during T&E regimen
5) Number of yearly injections
6) Number of unscheduled visits
7) Safety (Number of adverse events)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be after 2 years, an interim analysis is planned after 1 year. |
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |