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
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ClinicalTrials.gov Identifier: NCT03790852 |
Recruitment Status :
Active, not recruiting
First Posted : January 2, 2019
Last Update Posted : July 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Wet Age-related Macular Degeneration Retinal Vein Occlusion Diabetic Macular Edema | Drug: KSI-301 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | December 26, 2018 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | January 2022 |

Arm | Intervention/treatment |
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Experimental: KSI-301 2.5 mg
KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
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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
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Drug: KSI-301
Intravitreal injection |
- Incidence of ocular (study eye) and systemic adverse events [ Time Frame: Week 72 ]
- Mean change in central retinal thickness on optical coherence tomography [ Time Frame: Baseline, Week 72 ]
- Mean change in best corrected visual acuity [ Time Frame: Baseline, Week 72 ]

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Wet AMD Cohort
- Treatment naïve wet age-related macular degeneration involving the fovea.
- A lesion area <30 mm2 (12 disc areas) of any lesion type.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.
DME Cohort
- Treatment naïve diabetic macular edema.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
- Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
RVO Cohort
- Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
- Branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) are both eligible.
- 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:
- Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
- Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
- Prior intravitreal anti-VEGF therapy in the study eye.
DME Cohort:
- Initial diagnosis of DME of more than 6 months from screening in the study eye.
- Hard exudates in the fovea.
- Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
- Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
- 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:
- Initial diagnosis of RVO of more than 4 months from screening in the study eye.
- Active retinal or iris neovascularization in the study eye.
- Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
For all phase 1b subjects:
- Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of uveitis in either eye.
- 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.
- Prior vitrectomy surgery in the study eye.
- Active retinal disease other than the conditions under investigation.
- Active ocular or periocular infection or inflammation in either eye.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790852
United States, Arizona | |
Kodiak Sciences Investigative Site | |
Phoenix, Arizona, United States, 85053 | |
United States, California | |
Kodiak Sciences Investigative Site | |
Beverly Hills, California, United States, 90211 | |
Kodiak Sciences Investigative Site | |
Mountain View, California, United States, 94040 | |
Kodiak Sciences Investigative Site | |
Palo Alto, California, United States, 94303 | |
Kodiak Sciences Investigative Site | |
San Francisco, California, United States, 94109 | |
United States, Florida | |
Kodiak Sciences Investigative Site | |
Saint Petersburg, Florida, United States, 33711 | |
United States, Nevada | |
Kodiak Sciences Investigative Site | |
Reno, Nevada, United States, 89502 | |
United States, Pennsylvania | |
Kodiak Sciences Investigative Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Kodiak Sciences Investigative Site | |
Florence, South Carolina, United States, 29501 | |
United States, Texas | |
Kodiak Sciences Investigative Site | |
Abilene, Texas, United States, 79606 | |
Kodiak Sciences Investigative Site | |
Austin, Texas, United States, 78705 | |
Kodiak Sciences Investigative Site | |
Houston, Texas, United States, 77030 | |
Kodiak Sciences Investigative Site | |
The Woodlands, Texas, United States, 77384 |
Responsible Party: | Kodiak Sciences Inc |
ClinicalTrials.gov Identifier: | NCT03790852 |
Other Study ID Numbers: |
KSI-CL-101 |
First Posted: | January 2, 2019 Key Record Dates |
Last Update Posted: | July 2, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
DME wAMD RVO KSI-301 Kodiak |
Macular Degeneration Macular Edema Retinal Vein Occlusion Retinal Degeneration Retinal Diseases Eye Diseases |
Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |