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

Sponsor
Kodiak Sciences Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT03790852
Collaborator
(none)
121
11
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Dec 26, 2018
Actual Primary Completion Date :
Jun 2, 2021
Actual Study Completion Date :
Jun 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: KSI-301 2.5 mg

KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria

Drug: KSI-301
Intravitreal injection

Experimental: KSI-301 5 mg

KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria

Drug: KSI-301
Intravitreal injection

Outcome Measures

Primary Outcome Measures

  1. Incidence of ocular (study eye) and systemic adverse events [Week 72]

Other Outcome Measures

  1. Mean change in central retinal thickness on optical coherence tomography [Baseline, Week 72]

  2. Mean change in best corrected visual acuity [Baseline, Week 72]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retinal Research Institute, LLC Phoenix Arizona United States 85053
2 Retina Vitreous Associates Medical Group Beverly Hills California United States 90211
3 Northern California Retina Vitreous Associates Mountain View California United States 94040
4 Byers Eye Institute at Stanford Palo Alto California United States 94303
5 Retina Vitreous Associates of Florida Saint Petersburg Florida United States 33711
6 Sierra Eye Associates Reno Nevada United States 89502
7 Mid Atlantic Retina Philadelphia Pennsylvania United States 19107
8 Retina Research Institute of Texas Abilene Texas United States 79606
9 Austin Clinical Research Austin Texas United States 78750
10 Retina Consultants of Texas Bellaire Texas United States 77401
11 Retina Consultants of Texas Woodlands The Woodlands Texas United States 77384

Sponsors and Collaborators

  • Kodiak Sciences Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kodiak Sciences Inc
ClinicalTrials.gov Identifier:
NCT03790852
Other Study ID Numbers:
  • KSI-CL-101
First Posted:
Jan 2, 2019
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kodiak Sciences Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022