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: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders; MedDRA version: 20.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-002698-20-LV
• Lead Sponsor: Opthea Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 351

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 intra-retinal 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, including anti-VEGF-A therapy, photodynamic therapy, thermal laser, external beam radiation, steroids or other AMD therapy in the Study Eye. Oral supplements of vitamins and minerals are permitted.
2. Clinically significant ocular disorders (other than wet AMD), which may, in the Investigator’s opinion, interfere with assessment of visual acuity, assessment of safety, OCT, fluorescein angiography or fundus photography;
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, including presumed ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, and pathological myopia. Participants with retinal angiomatous proliferation (RAP) or idiopathic polypoidal choroidal vasculopathy (IPCV) are not excluded.
6. Cloudy ocular media, or inadequate pupillary dilatation, so as to prevent collection of fundus photographs and/or fluorescein angiograms of sufficient quality to be analysed by the Independent Reading Centre.
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. Absence of an intact posterior capsule is permitted if it occurred as a result of a YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens implant.
9. History of idiopathic or autoimmune-associated uveitis.
10. Any current ocular or periocular infection (participants may be re-screened once the infection has resolved or responded fully to treatment).
11. Intraocular pressure of greater than 25 mmHg (including participants with glaucoma or ocular hypertension who are stabilised on therapy).
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 (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant.
15. Prior pars plana vitrectomy.
16. Presence of an intravitreal device.
17. Retinopathy from diabetes, sickle cell disease or other cause.

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

GENERAL
1. Poorly controlled diabetes mellitus (defined as HbA1c > 7.0%).
2. Administration of systemic steroids within 3 months of screening.
3. Symptoms of heart failure leading to marked limitation on physical activity, or inability to perform any physical activity without discomfort.
4. Unstable angina, myocardial infarction or coronary artery revascularisation within 6 months of screening.
5. Ventricular tachyarrhythmia requiring ongoing treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified