# A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

> **NCT04108156** · PHASE3 · RECRUITING · sponsor: **Hoffmann-La Roche** · enrollment: 634 (estimated)

## Conditions studied

- Diabetic Macular Edema

## Interventions

- **DRUG:** PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
- **DRUG:** Intravitreal Ranibizumab 0.5 mg Injection
- **DRUG:** Ranibizumab refill exchange

## Key facts

- **NCT ID:** NCT04108156
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2019-09-30
- **Primary completion:** 2027-11-16
- **Final completion:** 2027-11-16
- **Target enrollment:** 634 (ESTIMATED)
- **Last updated:** 2026-03-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04108156

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04108156, "A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04108156. Licensed CC0.

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