RTH258 6 mg in patients with retina damage such as growth of abnormal blood vessels

A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RTH258 6mg Versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration - Efficacy and Safety of RTH258 versus Aflibercept

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004886-26-GB

Enrollment

660

Registered

2015-07-01

Start date

2015-09-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exudative senile macular degeneration of retina MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: RTH258 Product Code: RTH258 formerly ESBA1008 Pharmaceutical Form: Solution for injection Current Sponsor code: RTH258 / ESBA1008

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Subjects must give written informed consent •Subjects must be 50 years of age or older •Active CNV lesions secondary to AMD that affect the central subfield in the study eye •Total area of CNV must comprise as stated in the protocol Other protocol-defined inclusion criteria may apply. 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 614

Exclusion criteria

Exclusion criteria: •Any active intraocular or periocular infection or active intraocular inflammation in either eye •Central subfield of the study eye affected by fibrosis or geographic atrophy •Subject has received any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time. •History or evidence of the following in the study eye: • Intraocular or refractive surgery •Uncontrolled glaucoma as defined in the protocol •Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®) or pegaptanib (MACUGEN®) within the 4 week period prior to Baseline, or with Ranibizumab, 0.5 mg (LUCENTIS®) within the 2 week period prior to Baseline •Stroke or myocardial infarction or uncontrolled blood pressure Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in best-corrected visual acuity (BCVA) from Baseline to Week 48; Secondary Objective: To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA from Baseline averaged over the period Week 36 to Week 48 To estimate the proportion of q12 subjects (1 injection every 12 weeks) and its predictive value up to Week 48 in the RTH258 6 mg treatment arm To evaluate the efficacy of RTH258 6 mg relative to aflibercept 2 mg over the time period up to Week 96 by assessing changes in: BCVA, anatomical parameters and the “q8 treatment need” To assess visual function-related, subject reported outcomes. To assess safety and tolerability of RT258 relative to the comparator ;Primary end point(s): Change in BCVA from baseline to week 48;Timepoint(s) of evaluation of this end point: Baseline, Week 48	—

Measure

Time frame

Main Objective: To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in best-corrected visual acuity (BCVA) from Baseline to Week 48; Secondary Objective: To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA from Baseline averaged over the period Week 36 to Week 48 To estimate the proportion of q12 subjects (1 injection every 12 weeks) and its predictive value up to Week 48 in the RTH258 6 mg treatment arm To evaluate the efficacy of RTH258 6 mg relative to aflibercept 2 mg over the time period up to Week 96 by assessing changes in: BCVA, anatomical parameters and the “q8 treatment need” To assess visual function-related, subject reported outcomes. To assess safety and tolerability of RT258 relative to the comparator ;Primary end point(s): Change in BCVA from baseline to week 48;Timepoint(s) of evaluation of this end point: Baseline, Week 48

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Secondary

Measure	Time frame
Secondary end point(s): •Average change in BCVA from Baseline over the period Week 36 through Week 48. For each subject, this endpoint is defined as the average of the changes from baseline to Weeks 36, 40, 44 and 48. •q12 treatment status at Week 48 for subjects randomized to RTH258 6 mg. •q12 treatment status at Week 48 within the subjects randomized to RTH258 6 mg, with no q8 need during the 1st q12 cycle (Week 16 and Week 20). ; Timepoint(s) of evaluation of this end point: Baseline, weeks 36, 40, 44 and 48 Week 48 Week 48	—

Measure

Time frame

Secondary end point(s): •Average change in BCVA from Baseline over the period Week 36 through Week 48. For each subject, this endpoint is defined as the average of the changes from baseline to Weeks 36, 40, 44 and 48. •q12 treatment status at Week 48 for subjects randomized to RTH258 6 mg. •q12 treatment status at Week 48 within the subjects randomized to RTH258 6 mg, with no q8 need during the 1st q12 cycle (Week 16 and Week 20). ; Timepoint(s) of evaluation of this end point: Baseline, weeks 36, 40, 44 and 48 Week 48 Week 48

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Countries

Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam

Contacts

Public ContactEMEA Regulatory Affairs

Alcon Eye Care UK Ltd

eurmea.ra@alcon.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026