# A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

> **NCT04603937** · PHASE3 · TERMINATED · sponsor: **Kodiak Sciences Inc** · enrollment: 459 (actual)

## Conditions studied

- Diabetic Macular Edema

## Interventions

- **DRUG:** KSI-301
- **DRUG:** Aflibercept
- **OTHER:** Sham Procedure

## Key facts

- **NCT ID:** NCT04603937
- **Lead sponsor:** Kodiak Sciences Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-09-30
- **Primary completion:** 2023-04-27
- **Final completion:** 2023-08-31
- **Target enrollment:** 459 (ACTUAL)
- **Why stopped:** Study did not meet primary endpoint
- **Last updated:** 2024-08-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04603937

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04603937, "A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04603937. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*