Trial · NCT04503551

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

NCT04503551, Phase 3, Completed, Hoffmann-La Roche; results first posted 2025-11-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm. Trials, record NCT04503551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04503551

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
NCT number: NCT04503551
Status: Completed
Phases: Phase 3
Enrollment: 174 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Diabetic Retinopathy
Interventions: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection
First posted: 2020-08-07
Last updated: 2026-04-02
Results first posted: 2025-11-25

Source ClinicalTrials.gov

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52	Baseline, Week 52	ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy. The Cochran-Mantel Haenszel (CMH) method was used for analysis and weighted percentage of participants are estimated and reported in this outcome measure. Participants receiving supplemental treatments, prohibited therapy, or panretinal photocoagulation (PRP) were considered non-responders. Missing values not preceded by these intercurrent events were imputed using the last observation carried forward method. SD OCT= spectral-domain optical coherence tomography.
Secondary	Rate of Participants Developing a Vision-Threatening Complication or Center-involved Diabetic Macular Edema (CI-DME) Through Week 52	From Baseline through Week 52	A vision threatening complication is defined as proliferative DR (PDR) or anterior segment neovascularization (ASNV) or center-involved diabetic macular edema (CI-DME). CI-DME is defined as central foveal thickness (CST) ≥325 micrometres (μm) on spectral-domain optical coherence tomography (SD-OCT). Composite strategy (i.e., considered to be an event) was applied to participants who received supplemental or prohibited therapy or PRP in the study eye. The rate of participants was calculated using the Kaplan-Meier (KM) method.
Secondary	Rate of Participants Developing PDR or ASNV Through Week 52	From Baseline through Week 52	The KM method was used for analysis, and estimates are in terms of event rate. Composite strategy (i.e., considered to be an event) was applied to participants who received supplemental or prohibited therapy or PRP in the study eye.
Secondary	Rate of Participants Developing CI-DME Through Week 52	From Baseline through Week 52	CI-DME is defined as CST ≥325 μm on SD-OCT. The KM method was used for analysis, and estimated in terms of event rate. Composite strategy (i.e., considered to be an event) was applied to participants who received supplemental or prohibited therapy or PRP in the study eye.
Secondary	Rate of Participants Developing a ≥ 2-Step Worsening From Baseline on the ETDRS-DRSS Through Week 52	From Baseline through Week 52	ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR ), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy. Composite strategy (i.e., considered to be an event) was applied to participants who received supplemental or prohibited therapy or PRP in the study eye. The rate of participants developing ≥ 2-step worsening on the ETDRS-DRSS was calculated using the KM method.
Secondary	Percentage of Participants With a ≥ 3-Step Improvement From Baseline on the ETDRS-DRSS at Week 52	Week 52	ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR ), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy. Participants receiving supplemental treatments, prohibited therapy, or panretinal photocoagulation (PRP) were considered non-responders. Missing values not preceded by these intercurrent events were imputed using the last observation carried forward method. Percentages are rounded off to the nearest decimal point.
Secondary	Rate of Participants Developing a ≥ 3-Step Worsening From Baseline on the ETDRS-DRSS Through Week 52	From Baseline through Week 52	ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR ), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy. Composite strategy (i.e., considered to be an event) was applied to participants who received supplemental or prohibited therapy or PRP in the study eye. The rate of participants developing ≥ 3-step worsening on the ETDRS-DRSS was calculated using the KM method.
Secondary	Percentage of Participants With a ≥ 2-Step Improvement From Baseline on the ETDRS-DRSS Over Time	Baseline up to Week 112	ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale , from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy.
Secondary	Percentage of Participants With a ≥ 3-step Improvement From Baseline on the ETDRS-DRSS Over Time	Baseline up to Week 112	ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR ), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale , from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy.
Secondary	Time to First Development of Either PDR, ASNV, or CI-DME	Baseline up to Week 112

1 to 10 of 35Source ClinicalTrials.gov

See all 35 registered outcomes

Outcomes35

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52	Baseline, Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Rate of Participants Developing a Vision-Threatening Complication or Center-involved Diabetic Macular Edema (CI-DME) Through Week 52	From Baseline through Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Rate of Participants Developing PDR or ASNV Through Week 52	From Baseline through Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Rate of Participants Developing CI-DME Through Week 52	From Baseline through Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Rate of Participants Developing a ≥ 2-Step Worsening From Baseline on the ETDRS-DRSS Through Week 52	From Baseline through Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a ≥ 3-Step Improvement From Baseline on the ETDRS-DRSS at Week 52	Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Rate of Participants Developing a ≥ 3-Step Worsening From Baseline on the ETDRS-DRSS Through Week 52	From Baseline through Week 52	ITT Population included all participants who were randomized. Participants were grouped according to treatment assigned at randomization.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a ≥ 2-Step Improvement From Baseline on the ETDRS-DRSS Over Time	Baseline up to Week 112
SECONDARY	Percentage of Participants With a ≥ 3-step Improvement From Baseline on the ETDRS-DRSS Over Time	Baseline up to Week 112
SECONDARY	Time to First Development of Either PDR, ASNV, or CI-DME	Baseline up to Week 112

1 to 10 of 35Source ClinicalTrials.gov

See all 35 outcomes

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52	PDS With Ranibizumab 100 mg/mL	80.1	percentage of participants
Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52	Comparator Arm	9.0	percentage of participants
Rate of Participants Developing a Vision-Threatening Complication or Center-involved Diabetic Macular Edema (CI-DME) Through Week 52	PDS With Ranibizumab 100 mg/mL	7.1	percentage of participants
Rate of Participants Developing a Vision-Threatening Complication or Center-involved Diabetic Macular Edema (CI-DME) Through Week 52	Comparator Arm	47.0	percentage of participants
Rate of Participants Developing PDR or ASNV Through Week 52	PDS With Ranibizumab 100 mg/mL	1.0	percentage of participants
Rate of Participants Developing PDR or ASNV Through Week 52	Comparator Arm	42.4	percentage of participants
Rate of Participants Developing CI-DME Through Week 52	PDS With Ranibizumab 100 mg/mL	7.1	percentage of participants
Rate of Participants Developing CI-DME Through Week 52	Comparator Arm	47.0	percentage of participants
Rate of Participants Developing a ≥ 2-Step Worsening From Baseline on the ETDRS-DRSS Through Week 52	PDS With Ranibizumab 100 mg/mL	3.0	percentage of participants
Rate of Participants Developing a ≥ 2-Step Worsening From Baseline on the ETDRS-DRSS Through Week 52	Comparator Arm	46.4	percentage of participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PDS With Ranibizumab 100 mg/mL	106
Overall Study	STARTED	Comparator Arm	68
Overall Study	Safety Evaluable Population	PDS With Ranibizumab 100 mg/mL	105
Overall Study	Safety Evaluable Population	Comparator Arm	68
Overall Study	COMPLETED	PDS With Ranibizumab 100 mg/mL	0
Overall Study	COMPLETED	Comparator Arm	0
Overall Study	NOT COMPLETED	PDS With Ranibizumab 100 mg/mL	106
Overall Study	NOT COMPLETED	Comparator Arm	68

Source ClinicalTrials.gov

Adverse events47

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cataract	Eye disorders	PDS With Ranibizumab 100 mg/mL	6	105	8
other	Conjunctival haemorrhage	Eye disorders	PDS With Ranibizumab 100 mg/mL	79	105	93
other	Conjunctival hyperaemia	Eye disorders	PDS With Ranibizumab 100 mg/mL	12	105	12
other	Conjunctival oedema	Eye disorders	PDS With Ranibizumab 100 mg/mL	10	105	10
other	Diabetic retinal oedema	Eye disorders	PDS With Ranibizumab 100 mg/mL	6	105	7
other	Diabetic retinopathy	Eye disorders	PDS With Ranibizumab 100 mg/mL	7	105	8
other	Eye pain	Eye disorders	PDS With Ranibizumab 100 mg/mL	9	105	15
other	Foreign body sensation in eyes	Eye disorders	PDS With Ranibizumab 100 mg/mL	9	105	9
other	Iritis	Eye disorders	PDS With Ranibizumab 100 mg/mL	10	105	10
other	Ocular hypertension	Eye disorders	PDS With Ranibizumab 100 mg/mL	7	105	9

1 to 10 of 47Source ClinicalTrials.gov

See all 47 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PDS With Ranibizumab 100 mg/mL	0	106
Total, other adverse events	PDS With Ranibizumab 100 mg/mL	89	105
Total, serious adverse events	PDS With Ranibizumab 100 mg/mL	17	105

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40048178	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04503551/registered?page=2

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