A TWO-YEAR, RANDOMIZED, DOUBLE MASKED, MULTICENTER, THREE- ARM STUDY COMPARING THE EFFICACY AND SAFETY OF RTH258 VERSUS AFLIBERCEPT IN SUBJECTS WITH NEOVASCULAR AGE RELATED MACULAR GENERATIO

Not Applicable

• Conditions: -H164 Corneal neovascularisation; Corneal neovascularisation; H164

• Registration Number: PER-053-15
• Lead Sponsor: ALCON RESEARCH LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.-Subjects must give written informed consent before any
study related prcedures are performed.
2.- Subjects must be 50 years of age or older at Screening
3.- Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation lesions with a CNV component) in the study eye, confirmed by the Central Reading Center at Screening.
4.- Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye, confirmed by the CRC at Screening.
5.- Intra and/or subretinal fluid affecting the central subfield of the study eye, confirmed by the CRC at Screening.
6.- BCVA between 78 and 23 letters, inclusive in the study eye at Baseline using Early Treatment Dibetic Retinopathy Study (ETDRS) testing.

Exclusion Criteria

1.- Any active intraocular or periocular infection or active intraocular inflammation
2.- Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography any confirmed by the CRC at Screening.
3.- Total area of fibrosis >=50% of the total lesion in the study eye, coonfirmed by the CRC at Screening.
4.- Subretinal blood affecting the central subfield and/or >=50% of the lesion of the study eye, confirmed by the CRC at Screening.
5.- Subject has received any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time.
6.- Any history or evidence of a concurrent intraocular condition in the study eye, including retinal disease other than neovasuclar AMD, that, in the judgement of the investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition or that limits the potential gain visual acuity upon treatment with the investigational product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified