NCT02659098: PRELUDE

A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy

Completed Phase 2 Results posted Last updated 29 April 2025

What this trial tests

Phase 2 trial testing CNTO 2476 3.0 x 10^5 cells in Visual Acuity in 21 participants. Completed in 5 June 2019.

Timeline

4 December 2015

Primary endpoint
5 June 2019

5 June 2019

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	4 December 2015
Primary completion	5 June 2019
Estimated completion	5 June 2019
Sites	8 locations across United States

Drugs / interventions tested

• CNTO 2476 3.0 x 10^5 cells — full drug profile →
• Subretinal Delivery System

Conditions studied

• Visual Acuity — all drugs for Visual Acuity →
• Geographic Atrophy — all drugs for Geographic Atrophy →
• Macular Degeneration — all drugs for Macular Degeneration →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 55 to 90, any sex, with Visual Acuity or Geographic Atrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye Primary · Baseline and Month 1

Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.132	± 0.2093

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye Primary · Baseline and Month 2

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.073	± 0.2273

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye Primary · Baseline and Month 3

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.079	± 0.2502

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye Primary · Baseline and Month 6

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.090	± 0.2628

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye Primary · Baseline and Month 12

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.119	± 0.2598

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye Primary · Baseline and Month 18

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.107	± 0.2512

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye Primary · Baseline and Month 24

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.145	± 0.3065

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye Primary · Baseline and Month 30

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.112	± 0.3093

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye Primary · Baseline and Month 36

BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.211	± 0.3639

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye Primary · Baseline and Month 1

BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.017	± 0.0962

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye Primary · Baseline and Month 2

BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.027	± 0.0868

Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye Primary · Baseline and Month 3

BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Group	Value	95% CI
CNTO 2476 3.0*10^5 Cells	0.010	± 0.0960

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 36 Months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CNTO 2476 3.0*10^5 Cells

Serious: 5/21 (24%)

Deaths: 0/21

Serious adverse events (7 terms)

Reaction	System	CNTO 2476 3.0*10^5 Cells
Haemorrhagic Anaemia	Blood and lymphatic system disorders	—
Aortic Valve Stenosis	Cardiac disorders	—
Atrial Fibrillation	Cardiac disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Subarachnoid Haemorrhage	Nervous system disorders	—
Syncope	Nervous system disorders	—

Other adverse events (19 terms — click to expand)

Reaction	System	CNTO 2476 3.0*10^5 Cells
Conjunctival Haemorrhage	Eye disorders	—
Retinal Haemorrhage	Eye disorders	—
Visual Acuity Reduced	Eye disorders	—
Sensation of Foreign Body	General disorders	—
Vitreous Floaters	Eye disorders	—
Cataract Nuclear	Eye disorders	—
Neovascular Age-Related Macular Degeneration	Eye disorders	—
Hypertension	Vascular disorders	—
Atrial Fibrillation	Cardiac disorders	—
Anterior Chamber Cell	Eye disorders	—
Cataract	Eye disorders	—
Charles Bonnet Syndrome	Eye disorders	—
Conjunctival Oedema	Eye disorders	—
Visual Impairment	Eye disorders	—
Vitreous Detachment	Eye disorders	—
Urinary Tract Infection	Infections and infestations	—
Contusion	Injury, poisoning and procedural complications	—
Corneal Abrasion	Injury, poisoning and procedural complications	—
Fall	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Haemorrhagic Anaemia, Aortic Valve Stenosis, Atrial Fibrillation, Osteoarthritis, Lung Neoplasm Malignant, Subarachnoid Haemorrhage, Syncope.

Data from ClinicalTrials.gov NCT02659098 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CLINICAL ENDPOINTS FOR THE STUDY OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.
   Sadda SR, Chakravarthy U, Birch DG, Staurenghi G, et al · · 2016 · cited 114× · PMID 27652913 · DOI 10.1097/iae.0000000000001283
2. Cellular regeneration strategies for macular degeneration: past, present and future.
   Chichagova V, Hallam D, Collin J, Zerti D, et al · · 2018 · cited 75× · PMID 29503449 · DOI 10.1038/s41433-018-0061-z
3. Cell-based therapeutic strategies for replacement and preservation in retinal degenerative diseases.
   Jones MK, Lu B, Girman S, Wang S. · · 2017 · cited 72× · PMID 28111323 · DOI 10.1016/j.preteyeres.2017.01.004
4. The Role of Inflammation in Age-Related Macular Degeneration-Therapeutic Landscapes in Geographic Atrophy.
   Borchert GA, Shamsnajafabadi H, Hu ML, De Silva SR, et al · · 2023 · cited 28× · PMID 37626902 · DOI 10.3390/cells12162092
5. Cell-based therapies for retinal diseases: a review of clinical trials and direct to consumer "cell therapy" clinics.
   Hinkle JW, Mahmoudzadeh R, Kuriyan AE. · · 2021 · cited 28× · PMID 34635174 · DOI 10.1186/s13287-021-02546-9
6. Subretinal Human Umbilical Tissue-Derived Cell Transplantation Preserves Retinal Synaptic Connectivity and Attenuates Müller Glial Reactivity.
   Koh S, Chen WJ, Dejneka NS, Harris IR, et al · · 2018 · cited 25× · PMID 29431645 · DOI 10.1523/jneurosci.1532-17.2018
7. Neural Cells for Neurodegenerative Diseases in Clinical Trials.
   Fan Y, Goh ELK, Chan JKY. · · 2023 · cited 17× · PMID 37487111 · DOI 10.1093/stcltm/szad041
8. Geographic atrophy in age-related macular degeneration: phenotypic characterisation for clinical trial consideration.
   Borchert GA, Charbel Issa P, Xue K, MacLaren RE, et al · · 2026 · PMID 41721855 · DOI 10.1007/s00417-026-07153-z