A Phase I/II Study of RO4893594-PDS in Japanese Patients with Neovascular Age-Related Macular Degeneration and Japanese Patients with Diabetic Macular Edema

JRCT ID: jRCT2071210073

Registered date:02/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neovascular age-related macular degeneration (nAMD) and with diabetic macular edema (DME)
• Date of first enrollment: 07/03/2022
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Ranibizumab: After surgical insertion of an implant filled with ranibizumab filling solution into the study eye using an implant tool, the ranibizumab filling solution will be refilled directly into the implant inserted into the eye at 24-week intervals using a refill needle.

Outcome(s)

Primary Outcome

Safety endpoints
- Ocular adverse events
- Non-ocular adverse events
- Adverse device effects

Efficacy endpoint (nAMD cohort only)
- Mean change from baseline in BCVA score at Week 24

Secondary Outcome

Efficacy endpoints (nAMD cohort only)
- Mean change from baseline in BCVA score over time
- Mean change from baseline in BCVA score at Week 36 and at Week 40
- Mean change from baseline in center point thickness (CPT) over time
- Mean change from baseline in CPT at Week 24 and Week 36
- Proportions of patients who receive supplemental treatment with intravitreal ranibizumab 0.5 mg before the first refill and during the whole study period

PK outcome measures
- Serum ranibizumab concentration over time and PK parameters (area under drug concentration-time curve [AUC], maximum serum concentration [Cmax], etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion Criteria for Patients with Neovascular Age-Related Macular Degeneration
- Initial diagnosis of nAMD within 18 months prior to the screening visit
- Previous treatment with at least three anti-VEGF intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
- Demonstrated response to anti-VEGF intravitreal injections for nAMD
- BCVA of 34 letters or better (Snellen equivalent: 20/200 or better )

Inclusion Criteria for Patients with Diabetic Macular Edema
- Diagnosed with diabetes mellitus (Type 1 or Type 2)
- HbA1c level <=10% within 2 months prior to screening or at screening
- Macular thickening due to DME involving the fovea centralis, with CST >=325 mcm at screening or at a run-in visit (if run-in required)
- BCVA score = 78-25 letters (Snellen equivalent: 20/32 to 20/320)

Exclude criteria

Exclusion Criteria for Patients with nAMD
- Uncontrolled blood pressure
- History of other disease, metabolic dysfunction, physical examination finding, or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the IMP and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator
- Current systemic treatment for a confirmed active systemic infection
- Chronic use of oral corticosteroids
- History of vitreous surgery, submacular surgery, or other surgical intervention for nAMD
- Previous laser (any type) used for AMD treatment in study eye
- Previous intraocular device implantation
- Subretinal hemorrhage that involves the center of the fovea
- Subfoveal fibrosis or subfoveal atrophy

Exclusion Criteria for Patients with DME
- Active endophthalmitis (Grade 1 or above)
- Uncontrolled ocular hypertension or uncontrolled glaucoma or (in the investigator's opinion) a possibility that the patient might require a minimally invasive glaucoma surgery surgery during the study
- Uncontrolled blood pressure

Related Information

• Primary Sponsor: Ogura Yuichiro