Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007584

Trial Description

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Title

A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (SPECTRI)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
study evaluating the efficacy and safety of lampalizumab administered by intravitreal
injections in patients with geographic atrophy (GA) secondary to age-related macular
degeneration (AMD).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007584
  •   2016/01/26
  •   2014/07/15
  •   no
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Secondary IDs

  •   2014-000106-35 
  •   NCT02247531  (ClinicalTrials.gov)
  •   GX29185  (Hoffmann-La Roche)
  •   2014-000106-35 
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Health Condition or Problem studied

  •   Geographic Atrophy
  •   H35.3 -  Degeneration of macula and posterior pole
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Interventions/Observational Groups

  •   Drug: Lampalizumab
  •   Other: Sham
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Change in GA area, as assessed by retinal imaging; time frame: From baseline to Week 48

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Secondary Outcome

- Change in best corrected visual acuity (BCVA); time frame: From baseline to 2 years
- Change in additional measures of visual function; time frame: From baseline to 2 years

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Denmark
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Mexico
  •   Netherlands
  •   Peru
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Slovakia
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/10/31
  •   936
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

- Participants aged >/= 50 years

- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active
choroidal neovascularization (CNV) in both eyes

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Exclusion Criteria

Ocular Exclusion Criteria: Study Eye

- History of vitrectomy surgery, submacular surgery, or other surgical intervention for
AMD

- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
occlusion, and proliferative diabetic retinopathy

- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection,
anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular
Exclusion Criteria: Both Eyes

- GA in either eye due to causes other than AMD

- Previous treatment with eculizumab, lampalizumab and/or fenretinide

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Reference Study ID Number: GX29185 www.roche.com/about_roche/roche_worldwide.htm 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/03/15
* This entry means the parameter is not applicable or has not been set.