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Completed

NCT Number: NCT01397409

Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Exudative age-related macular degeneration
  • Best-corrected visual acuity between 20/32 and 20/320 in the study eye

Exclusion criteria

  • Near-sightedness of 8 diopters or more
  • Uncontrolled glaucoma in the study eye
  • Cataract surgery or Lasik within the last 3 months
  • Any active ocular infection or inflammation

Treatment and study plan

AGN-150998

Drug

AGN-150998 Intravitreal injection.

ranibizumab

Drug

Ranibizumab 0.5 mg given by intravitreal injection.

Other names: Lucentis®

Sham Injection

Other

Stage 3: Sham injection at Weeks 12 and 16.

Primary outcomes

  1. Highest Tolerated Dose (HTD) of AGN-150998

    Time frame: 24 Weeks

    Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.

  2. Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Time frame: Baseline, Week 4

    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.

  3. Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease

    Time frame: Baseline, Week 16

    Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.

  4. Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Week 16

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Secondary outcomes

  1. Stage 2: Time Between Second Treatment and Recurrence of Active Disease

    Time frame: 32 Weeks

    Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.

  2. Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Time frame: Baseline, Week 4

    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.

  3. Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Week 4

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  4. Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Time frame: Baseline, Week 4

    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.

  5. Stage 3: Change From Baseline in BCVA in the Study Eye

    Time frame: Baseline, Week 4

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 19, 2011
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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