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Clinical Trials/EUCTR2009-015681-55-DE
EUCTR2009-015681-55-DEActive, not recruitingPhase 1

A Dose-Escalation Study of AL-39324 Suspension versus Lucentis™ for the Treatmentof Exudative Age-Related Macular Degeneration - Wet AMD AL-39324 Treatment Examination (WALTZ)

Alcon Research, Ltd.0 sites0 target enrollmentStarted: November 10, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 35
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 35

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

Investigators

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