| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Exudative Age-related macular degeneration |
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| E.1.1.1 | Medical condition in easily understood language |
| "Wet" age-related macular degeneration |
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| E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10067791 |
| E.1.2 | Term | Wet macular degeneration |
| E.1.2 | System Organ Class | 10015919 - Eye disorders |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10025409 |
| E.1.2 | Term | Macular degeneration |
| 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 |
| The objective of this study is to assess the safety, tolerability and the effects of treatment on ocular outcomes following a single intravitreal administration of AL-39324 suspension in subjects with exudative AMD. |
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| E.2.2 | Secondary objectives of the trial |
| The mean reduction from baseline through Month 1 of central foveal thickness due to exudative AMD, and mean change in BCVA from baseline through the time of patients’ escape to standard of care |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subject must be willing to give written informed consent, make the required study visits and follow instructions
2. Subject must be 50 years of age or older
3. The study eye must have:
• primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions
• a lesion area < 12 disc areas (30 mm2) of any lesion type (predominantly classic, minimally classic or occult)
• a total area of CNV (including both classic and occult components) encompassed within the lesion >50% of the total lesion area (defined as angiographic evidence of neovascularization associated contiguous areas of serous elevation of the RPE, elevated blocked fluorescence, and/or late staining)
• a new diagnosis of exudative AMD or evidence of recent disease progression (within the last 3 months) if the CNV in the study eye is minimally classic or occult, defined as having experienced a loss of at least 1 line of vision (5 ETDRS letters or one Snellen line) or change in lesion size of more than 1 disk area (2.54 mm2) or the appearance of new blood in the lesion
• retinal edema as measured by a central retinal thickness of >340 m on a Spectralis OCT imaging system
• a best-corrected visual acuity (BCVA) of 73 letters (20/40 Snellen equivalent) to 34 letters (20/200 Snellen equivalent), inclusive
• clear ocular media and adequate pupil dilation to permit good quality photographic imaging
4. Subject’s fellow eye best corrected visual acuity (BCVA) must be 34 letters (Snellen equivalent 20/200) or better
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| E.4 | Principal exclusion criteria |
1. Subject has received any previously administered therapy, approved or investigational, for exudative AMD in the study eye
2. Any current or history of ocular disease in the study eye that, in the opinion of the Investigator, may confound assessment of the macula or affect central vision, other than non-exudative AMD (such as: vein occlusion, diabetic retinopathy, uveitis, angioid streaks, histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole)
3. Any active intraocular inflammation in the study eye.
4. Any vitreous hemorrhage or a history of rhegmatogenous retinal detachment in the study eye
5. History or evidence of the following surgeries:
• penetrating keratoplasty or vitrectomy in the study eye
• cataract surgery or Lasik in the study eye within the last 3 months
• OR expected to have cataract removal surgery in the study eye during the study
6. Any active ocular infections in either eye (such as: blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis)
7. A history or medical diagnosis of uncontrolled glaucoma (defined as intraocular pressure >25 mmHg despite treatment with anti-glaucoma medication) or advanced glaucoma resulting in a cup/disc ratio >0.8 in the study eye or glaucoma filtration surgery in the study eye
8. Aphakia in the study eye or violation of the posterior capsule in the study eye, unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior, posterior intraocular lens implantation
9. Current use or likely to require treatment with a systemic medication known to be toxic to the lens; including psoralen, risedronic acid and Tamoxifen
10. Current use or history of chronic therapy with systemic or topical ocular corticosteroids (defined as multiple doses taken daily for 3 or more consecutive days at any time within 6 months prior to enrollment)
11. History of a medical condition (disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of study medication (e.g., unstable or progressive cardiovascular, pulmonary, Parkinson's, liver or renal disease, cancer or dementia)
12. Any screening laboratory result (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is not suitable for study participation; any screening liver function test value [AST (SGOT), ALT (SPGT), alkaline phosphatase, GGT, total bilirubin, direct bilirubin, indirect bilirubin, and LDH] that is more than twice the upper limit of normal
13. History of severe or serious hypersensitivity to any components of the test article (see Section 6.1.1. Study Medication) or in the Investigator’s opinion, clinically relevant sensitivity to fluorescein dye
14. Female of childbearing potential (those who are not surgically sterilized or post-menopoausal) may not participate in the study if any of the following conditions exist:
• Pregnant (positive serum pregnancy test at screening) or intend to become pregnant
• Nursing (lactating)
• Do not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal –oral, implantable, transdermal or injectable contraceptives; mechanical – spermicide in conjunction with a barrier such as condom or diaphragm, IUD or surgical sterilization of partner
Note: All females of childbearing potential must consent to a serum pregnancy test upon entering and exiting the study
Note: Instruct each female of childbearing potential to immediately inform the investigator if she becomes pregnant during the study. Should this occur, the Investigator shall immediately contact the Sponsor as detailed in Section 9.3
15. Participation in an investigational drug or device study within 30 days of screening
16. Medical Monitor opinion that a person is ineligible to participate in the study for a sound medical reason prior to enrollment into the study
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary safety endpoint of the study is the incidence of targeted adverse events that occur in the study eye within 7 days of the intravitreal injection.
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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) |
The secondary endpoint of the study is the mean reduction from baseline of central foveal thickness due to exudative AMD at Day 30.
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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 | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
| patient and evaluating investigator are blinded |
|
| 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 | 6 |
| 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 | 3 |
| 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 |
| Australia |
| Austria |
| Germany |
| Israel |
| Italy |
| Switzerland |
| United States |
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| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| 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 |
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