E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057934 |
E.1.2 | Term | Diabetic macular edema |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 |
To evaluate whether laser photocoagulation prolongs treatment effect of anti-VEGF for DME. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age ≥ 18 years.
2. Able to read and sign the written informed consent.
3. Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT ≥ 340 micron (see Section 7.1 for argumentation for chosen cut-off value).
4. VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart (Snellen decimal equivalent: 0.08 – 0.63).
5. If both eyes are eligible, the eye with the highest CFT will be selected as the study eye. If both eyes have equal CFT, the eye with the most recent record of presence of DME will be selected as the study eye. The fellow eye will receive treatment according to the current standard of care at the investigator’s discretion.
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E.4 | Principal exclusion criteria |
1. Previous laser photocoagulation therapy within the last 6 months.
2. Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months.
3. Previous subtenon’s or intravitreal triamcinolone injection within the last 6 months.
4. Steroid implants of any kind within the last 3 years.
5. Macular ischemia confirmed by fluorescein angiography (FA).
6. Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT.
7. Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia.
8. Any ocular surgery/intervention within last three months before enrollment.
9. Any ocular surgery/intervention anticipated during the course of the study.
10. Ocular opacities hampering adequate imaging of the posterior pole.
11. Poor control of DM with glycated hemoglobin (HbA1c) of ≥ 86% in last 6 months.
12. Allergy to fluorescein or anti-VEGF, or any of its preservatives.
13. Pregnancy.
14. Non-Caucasian or Asian descent.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of failures at 72 weeks.
Definition of failure:
> 50 micron increase in central foveal thickness compared to week 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 24 weeks, 72 weeks. |
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E.5.2 | Secondary end point(s) |
Central foveal thickness.
Visual acuity.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, week 24, week 72. |
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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) | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
(1: avastin plus sham laser) vs. (2: avastin plus laser) vs. (3: avastin plus repeated laser) |
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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 | 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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |