A Study to Evaluate the Safety and Tolerability of EXN407

  • STATUS
    Recruiting
  • End date
    May 20, 2022
  • participants needed
    48
  • sponsor
    Exonate Limited
Updated on 23 June 2021
Investigator
Mike Taylor
Primary Contact
Centre for Eye Research Australia (CERA) (5.9 mi away) Contact
+9 other location

Summary

This first in human (FIH), Phase Ib/II study of EXN407 is a randomised, double-masked, vehicle-controlled, multiple dose, dose-escalating study to evaluate the safety and tolerability of EXN407 in subjects with centre involved Diabetic Macular Oedema (DMO), with Centre-subfield macular thickness (CMT) between 280-420 m and Best corrected visual acuity (BCVA) better than approximate Snellen equivalent 20/32 (6/9, 78 letters) in the study eye, which is considered secondary to diabetes mellitus. For brevity, the BCVA criteria will be noted as 20/32 (6/9).

This study will provide a basis for further clinical development of EXN407 ophthalmic solution.

Details
Condition Diabetic Macular Edema
Treatment EXN407
Clinical Study IdentifierNCT04565756
SponsorExonate Limited
Last Modified on23 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is at least 18 years of age inclusive, at the time of signing the informed consent
BCVA better than approximate Snellen equivalent 20/32 (6/9, 78 letters) in the study eye using the ETDRS visual acuity scale at Screening. Subjects should have less than a 10% variance in this measure at Screening and baseline visit
Ocular media is consistent with SD-OCT imaging and cataracts are not expected in the subject for the duration of the study
The subject has no other retinal disease
Subject or the subject's partner successfully demonstrates their ability to self-administer/administer eye drops at Screening, with multiple attempts allowed at the discretion of the Investigator

Exclusion Criteria

Any other retinal disease in the study eye, other than centre involved DMO or diabetic retinopathy
Poor vision (VA 6/60 or worse) in the contralateral eye
Intraocular inflammation (including trace or greater) in the study eye. History of idiopathic or autoimmune uveitis in either eye
Prior or current use of intravitreal ranibizumab, bevacizumab, aflibercept or the use of systemic or intraocular steroids in either eye
Within 180 days prior to the Screening visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol)
History of (within 90 days of Screening date) cerebral vascular accident (stroke) or MI
Significant renal impairment including subjects on chronic renal dialysis and subjects with a history of nephrectomy or kidney transplant (regardless of renal function)
History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses
Positive pregnancy test (all female subjects of childbearing potential must have a urine -human chorionic gonadotropin [hCG] pregnancy test performed at Screening and within 7 days prior to randomisation) or is known to be pregnant or lactating
Known to have, or history of a positive test result for, hepatitis B or C, HIV, syphilis, tuberculosis, or COVID-19
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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