E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular age-related macular degeneration (AMD). |
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E.1.1.1 | Medical condition in easily understood language |
Neovascular age-related macular degeneration (AMD). |
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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 assess the safety and efficacy of abicipar compared with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration (AMD). |
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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 |
General Inclusion Criteria 1. Male or female patients, 50 years of age or older at the time of informed consent 2. Patient has completed/signed an informed consent prior to conduct of any study-related procedures or examinations, is able to follow study instructions, and is likely to complete all required visits 3. Patient has provided, at screening, written documentation in accordance with the relevant country and local privacy requirements (eg, Written Authorization for Use and Release of Health and Research Study Information and written Data Protection consent, as required by regional health authorities)
Ocular Inclusion Criteria (Study Eye) 4. Presence of active subfoveal and/or juxtafoveal CNV secondary to AMD with retinal fluid on optical coherence tomography (OCT) and/or fluorescein leakage under the fovea as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1) 5. Area of the CNV lesion, including both classic and occult components, must be > 50% of the total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1) 6. BCVA ≤ 73 and ≥ 24 letters (20/40 to 20/320 Snellen equivalents, respectively) at screening and at baseline (day 1, prior to treatment) visits 7. Sufficiently clear ocular media and adequate pupil dilation to permit good quality photographic imaging
Ocular Inclusion Criteria (Non-study Eye) 8. BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (day 1), prior to treatment |
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E.4 | Principal exclusion criteria |
General Exclusion Criteria 1. Females who are pregnant, nursing, planning a pregnancy during the study, or who are of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study. A pregnancy test administered to women of childbearing potential at the baseline visit (day 1, prior to treatment) must be negative for the patient to receive study medication 2. History or current evidence of hypersensitivity to any components of the study medication or clinically relevant sensitivity to fluorescein, as assessed by the investigator at screening 3. History or current evidence of hypersensitivity, allergy, or anaphylactic reaction to iodine as assessed by the investigator at screening 4. Participation in any investigational device study within 30 days, or participation in any investigational drug study within 30 days or 5 half-lives of the respective investigational drug (whichever is longer) prior to baseline (day 1) 5. History or current evidence of a medical condition (including physical examination finding, or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of study medication, adherence to the scheduled study visits, safe participation in the study or confound study results (eg, metabolic dysfunction, uncontrolled hypertension, autoimmune disease, infection, inflammatory condition, advanced coronary artery disease, cerebral vascular disease, other unstable or progressive cardiovascular or pulmonary condition, Parkinson's disease, liver or renal failure, cancer, or dementia) 6. Treatment with systemic anti-VEGF medication (eg, bevacizumab, ziv-aflibercept) or VEGF-receptor inhibitor (eg, sunitinib, sorafenib, pazopanib) within 3 months prior to baseline (day 1) 7. Use of systemic (eg, oral, intravenous, intramuscular, rectal, or extensive dermal [> 20% total body surface area]) corticosteroids within 5 days prior to baseline (day 1)
Ocular Exclusion Criteria (Either Eye) 8. Active ocular/intraocular infection at baseline (day 1) 9. History of recurrent or currently active ocular/intraocular inflammation (eg, uveitis) at baseline (day 1) 10. History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or any retinal vascular disease other than AMD at screening
Ocular Exclusion Criteria (Study Eye) 11. Presence of CNV other than AMD at screening, eg, pathologic myopia, ocular histoplasmosis, and angioid streaks 12. Spherical equivalent of the refractive error of -8 diopters of myopia or worse (prior to cataract or refractive surgery) at screening 13. Any active iris neovascularization, or current evidence of vitreous hemorrhage, or retinal detachment (considered by the investigator to significantly affect central vision) prior to baseline (day 1) 14. Previous use of verteporfin PDT or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region of the study eye 15. Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD, approved or investigational, except dietary supplements or vitamins 16. Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD 17. Treatment with ocular corticosteroid injections or implants (eg, by subconjunctival, periocular, or intravitreal routes of administration) within 6 months prior to baseline (day 1), or with fluocinolone acetonide implant (Iluvien™) within 36 months prior to baseline (day 1) 18. Previous or concurrent laser treatment for macular drusen 19. Total lesion size > 12 disc area (DA) (30.5 mm2 including blood, neovascularization, and fibrosis) as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1) 20. Presence of a retinal pigment epithelium (RPE) tear or rip lesion involving the macula as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1) 21. Structural damage to the center of the macula that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the RPE, and retinal fibrosis/scarring, as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1) 22. Macular scar or fibrosis, making up > 50% of total lesion area as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
For the remaining exclusion criteria, please see protocol pages 23 and 24. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with stable vision (i.e. patients who lose fewer than 15 letters in BCVA) from baseline at week 52. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Mean change from baseline in BCVA at week 52 - Mean change from baseline in CRT as assessed with SD-OCT and quantified by the central reading center at week 52 - Proportion of patients with a gain of 15 or more ETDRS letters in BCVA from baseline at week 52 - Mean change from baseline in NEI-VFQ-25 composite score at week 52 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 62 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Austria |
Chile |
Colombia |
Czech Republic |
France |
Germany |
Hong Kong |
Israel |
Korea, Republic of |
Latvia |
New Zealand |
Philippines |
Portugal |
Singapore |
Spain |
Switzerland |
United States |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |