A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovascular age-related macular degeneratio

Phase 1

Conditions: eovascular age-related macular degeneration (wet AMD)
MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2017-002698-20-IT

Lead Sponsor: OPTHEA LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 366

Inclusion Criteria

STUDY EYE
1. Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal
CNV lesion (1-199 µm from the fovea) with subfoveal involvement
(demonstrated by leakage on fluorescein angiography (FA) and/or intraretinal
or sub-retinal fluid on spectral-domain optical coherence
tomography
[SD-OCT]) secondary to age-related macular degeneration
(AMD).
Active CNV as measured on FA must constitute at least 50% of
the
lesion area, with a total lesion size of = 30.5 mm2. The lesion may
contain
classic and/or occult CNV, but any occult CNV present must
measure
< 10 mm2 on the FA. The characteristics of each lesion must be
confirmed
by the Independent Reading Centre.
2.
A best corrected (ETDRS) visual acuity (BCVA) score between 60 and
25
(inclusive) letters (Snellen equivalent of 20/63 (feet) or 6/21
(metres)
and 20/320 (feet) or 6/96 (metres) respectively).
GENERAL
1. Willing and able to provide written informed consent.
2. Male or female participants at least 50 years of age.
3. Able to understand and willing to comply with study protocol
procedures and restrictions.
4. If female and of child-bearing potential: Pregnancy test at Screening
is negative, and agrees to use a highly effective method of contraceptive
for the duration of the study and for at least 3 months following the last
dose of study medication.
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 326

Exclusion Criteria

STUDY EYE
1 Any previous treatment for wet AMD

2 Clinically significant ocular disorders other than wet

3 Haemorrhage measuring more than 50% of total lesion area

4 Fibrosis involving either the fovea centre or measuring more than
25% of the total lesion area and/or juxtafoveal or sub-foveal geographic
Atrophy

5 Choroidal neovascularisation due to causes other than AMD

6 Cloudy ocular media, or inadequate pupillary dilatation

7 Presence of intraocular inflammation (= trace cell or flare), significant
epiretinal membrane or vitreomacular traction, macular hole or vitreous
haemorrhage

8 Aphakia or absence of the posterior capsule

9 History of idiopathic or autoimmune-associated uveitis
10. Any current ocular or periocular infection

11 Intraocular pressure of greater than 25 mmHg

12 Myopia, or known former myopia, with a spherical equivalent of
Greater than 8 dioptres

13 Intraocular surgery within 6 months prior to screening, except for
Cataract surgery that is excluded within 3 months of Screening.

14 History of any of the following conditions or procedures:
Rhegmatogenous retinal detachment, filtering surgery
glaucoma drainage device, or corneal transplant.

15 Prior pars plana vitrectomy.

16 Presence of an intravitreal device.
17 Retinopathy

NON-STUDY EYE
History of idiopathic, autoimmune-associated, or infectious uveitis

GENERAL
1 diabetes mellitus
2 Administration of systemic steroids within 3 months of screening
3 Symptoms of heart failure
4 Unstable angina, myocardial infarction or coronary artery revascularisation within 6 months of screening.
5 Ventricular tachyarrhythmia requiring ongoing treatment
6 Vascular stenting within 6 months of screening
7 Cerebrovascular event
8 Diastolic blood pressure > 100 mmHg at screening.
9 Renal failure requiring dialysis or transplant.
10. ALT or AST = 2 x upper limit of normal or total bilirubin = 1.5
x ULN unless due to genetically confirmed Gilbert's disease
11 Any major surgical procedure
12 Active systemic infection
13 Malignancy within 5 years of screening, with the exception of
carcinoma in situ, non-melanoma skin cancers and prostate cancer not
requiring treatment or on stable (> 6 months) treatment with hormone
therapy
14 Known serious allergies to the fluorescein or hypersensitivity to
any of the listed excipients in the OPT-302 formulation or components of
the ranibizumab formulation
15 Pregnant, within 3 months after the end of pregnancy, planning to
become pregnant, or lactating.
16 Previous administration of anti-VEGF-A therapies except by intravitreal injection in the non-Study Eye
17 Administration of an investigational drug or ocular device within 30
days of screening, or 5 half-livesor any prior
treatment with OPT-302
18 Any social or medical condition that, in the Investigator's opinion,
would preclude enrolment into the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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