PDS Implant Pre-Filled with 100 mg/mL Ranibizumab for Diabetic Retinopathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetic RetinopathyPDS Implant Pre-Filled with 100 mg/mL Ranibizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the effects of ranibizumab given through the Port Delivery System in people with diabetic retinopathy without center-involved diabetic macular edema.

Eligible Conditions
  • Diabetic Retinopathy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 35 Secondary · Reporting Duration: Baseline up to Week 112

Week 52
Rate of participants developing a ≥ 3-step worsening from baseline on the ETDRS-DRSS through Week 52
Week 112
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured on the ETDRS chart over time
Change from baseline in CST as measured on SD-OCT over time
Sodium dodecyl sulfate
Incidence and severity of non-ocular adverse events
Incidence and severity of ocular adverse events
Incidence, severity, and duration of adverse events of special interest
Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 days after initial implant insertion) and follow-up period (> 37 days after implant insertion surgery)
Serum
PK parameter half-life (t1/2) after PDS implant insertion
Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab within each refill-exchange interval
Percentage of participants who lose <15, < 10 and < 5 letters in BCVA from baseline over time
Percentage of participants with a BCVA score of 69 letters (20/40 approximate Snellen equivalent) or better over time
Percentage of participants with a ≥ 2-step improvement from baseline on the ETDRS-DRSS over time
Percentage of participants with a ≥ 3-step improvement from baseline on the ETDRS-DRSS over time
Percentage of participants with absence of intraretinal fluid, subretinal fluid or both (as measured in the central 1 mm subfield) over time
Percentage of participants with adverse device effects
Percentage of participants with serious adverse device effects
Pharmacokinetic (PK) parameter value area under the concentration- time curve
Prevalence of anti-drug antibodies (ADAs) prior to study treatment and incidence of ADAs after study treatment
Prevalence of neutralizing antibodies at baseline and incidence of neutralizing antibodies during the study
Serum concentration of ranibizumab observed over time
Time to first development of CI-DME
Time to first development of PDR or ASNV
Time to first development of a ≥ 2-step worsening from baseline on the ETDRS-DRSS
Time to first development of a ≥ 3-step worsening from baseline on the ETDRS-DRSS
Time to first development of either PDR, ASNV, or CI-DME
Week 52
Abetalipoproteinemia
Week 52
Rate of participants developing CI-DME through Week 52
Rate of participants developing PDR or ASNV through Week 52
Rate of participants developing a vision-threatening complication (defined as PDR, ASNV, or CI-DME [defined as central foveal thickness [CST] ≥325 μm on spectral-domain optical coherence tomography [SD-OCT]) through Week 52
Rate of participants developing a ≥ 2-step worsening from baseline on the ETDRS-DRSS through Week 52
Week 52
Percentage of participants who report preferring PDS treatment to intravitreal ranibizumab treatment, as measured by the PPPQ at Week 52
Percentage of participants with a ≥ 3-step improvement from baseline on the ETDRS-DRSS at Week 52
Percentage of participants with a ≥ 3-step worsening from baseline on the ETDRS-DRSS at Week 52
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 52

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

PDS Arm
1 of 1

Experimental Treatment

174 Total Participants · 1 Treatment Group

Primary Treatment: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab · No Placebo Group · Phase 3

PDS ArmExperimental Group · 2 Interventions: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to week 112

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,067,909 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
550 Patients Enrolled for Diabetic Retinopathy
Clinical TrialsStudy DirectorHoffmann-La Roche
2,148 Previous Clinical Trials
875,999 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
104 Patients Enrolled for Diabetic Retinopathy

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 or older at the time of signing the Informed Consent Form.
You have diabetes mellitus.
You have a HbA1c level of ≤12% within 2 months prior to screening or at screening.
The study eye must be normal.
You have moderate or severe NPDR (ETDRS-DRSS level 47 or 53).
You have a visual acuity of at least 69 letters (20/40 approximate Snellen equivalent or better).

Who else is applying?

What state do they live in?
Texas33.3%
New York33.3%
Maryland16.7%
Other16.7%
How old are they?
18 - 6580.0%
65+20.0%
What site did they apply to?
Retina Group of Washington25.0%
Midwest Vision Research Foundation25.0%
Retina Consultants of Texas25.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Met criteria80.0%
Did not meet criteria20.0%