Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ksi-cl-101
Previous Study | Return to List | Next Study

Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03790852
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

Tracking Information
First Submitted Date  ICMJE December 27, 2018
First Posted Date  ICMJE January 1, 2019
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE December 26, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
Incidence of ocular (study eye) and systemic adverse events [ Time Frame: Week 36 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03790852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 31, 2018)
  • Mean change in central retinal thickness on optical coherence tomography [ Time Frame: Baseline, Week 36 ]
  • Mean change in best corrected visual acuity [ Time Frame: Baseline, Week 36 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
Official Title  ICMJE A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Brief Summary This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wet Age-related Macular Degeneration
  • Retinal Vein Occlusion
  • Diabetic Macular Edema
Intervention  ICMJE Drug: KSI-301
Intravitreal injection
Study Arms  ICMJE
  • Experimental: KSI-301 2.5 mg
    KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
    Intervention: Drug: KSI-301
  • Experimental: KSI-301 5 mg
    KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
    Intervention: Drug: KSI-301
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Wet AMD Cohort

  1. Treatment naïve wet age-related macular degeneration involving the fovea.
  2. A lesion area <30 mm2 (12 disc areas) of any lesion type.
  3. BCVA ETDRS letter score ≤ 78 and ≥ 23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye.
  4. Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.

DME Cohort

  1. Treatment naïve diabetic macular edema.
  2. BCVA ETDRS letter score ≤ 78 and ≥ 23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye.
  3. Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
  4. Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.

RVO Cohort

  1. Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment.
  2. BCVA ETDRS letter score ≤ 78 and ≥ 23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye.
  3. Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
  4. Branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) are both eligible.
  5. Decrease in vision in the study eye determined by the investigator to be primarily the result of macular edema secondary to RVO.

General Inclusion Criteria

  • Adults ≥ 21 years.

Exclusion Criteria:

Wet AMD Cohort:

  1. Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
  2. Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
  3. Prior intravitreal anti-VEGF therapy in the study eye.

DME Cohort:

  1. Initial diagnosis of DME of more than 6 months from screening in the study eye.
  2. Hard exudates in the fovea.
  3. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
  4. Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
  5. Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.

RVO Cohort:

  1. Initial diagnosis of RVO of more than 4 months from screening in the study eye.
  2. Active retinal or iris neovascularization in the study eye.
  3. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.

For all phase 1b subjects:

  1. Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
  2. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  3. Any history of uveitis in either eye.
  4. Significant media opacities, including visually significant cataract, in the study eye that might interfere with visual acuity assessments, optical coherence tomography, fundus photography, or with examination of the eye for assessment of safety.
  5. Prior vitrectomy surgery in the study eye.
  6. Active retinal disease other than the conditions under investigation.
  7. Active ocular or periocular infection or inflammation in either eye.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Ehrlich, MD, PhD 6502810836 jehrlich@kodiak.com
Contact: Pablo Velazquez-Martin, MD 6502810844 pablovm@kodiak.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03790852
Other Study ID Numbers  ICMJE KSI-CL-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kodiak Sciences Inc
Study Sponsor  ICMJE Kodiak Sciences Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kodiak Sciences Inc
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP