NCT00665106 is a Phase 1 clinical trial of NOVA63035 "Corticosteroid" in Diabetic Macular Edema, sponsored by Santen SAS.

Who is sponsoring NCT00665106?

NCT00665106 is sponsored by Santen SAS.

What drugs are being tested in NCT00665106?

Interventions in NCT00665106: NOVA63035 "Corticosteroid".

What condition does NCT00665106 study?

NCT00665106 studies Diabetic Macular Edema.

Is NCT00665106 still recruiting?

NCT00665106 is currently completed. Last updated 26 May 2015.

Last reviewed 2015-05-26 · How we verify

NCT00665106

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Completed Phase 1 Last updated 26 May 2015

What this trial tests

Phase 1 trial testing NOVA63035 "Corticosteroid" in Diabetic Macular Edema in 20 participants. Completed in 1 September 2011.

Timeline

1 April 2008

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	Santen SAS
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	20
Start date	1 April 2008
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	1 location across United States

Drugs / interventions tested

NOVA63035 "Corticosteroid" — full drug profile →

Conditions studied

Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Santen SAS — full company profile →

Who can join

18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Ocular safety
Time frame: Over one year

Sponsor's own description

Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy

Publications & conference data

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

Role of Inflammation in Classification of Diabetic Macular Edema by Optical Coherence Tomography.
Chung YR, Kim YH, Ha SJ, Byeon HE, et al · · 2019 · cited 50× · PMID 31930145 · DOI 10.1155/2019/8164250
Experiment-Based Interventions to Diabetic Retinopathy: Present and Advances.
Liu S, Ju Y, Gu P. · · 2022 · cited 8× · PMID 35806008 · DOI 10.3390/ijms23137005

Verify or expand the search:

Other recruiting trials for Diabetic Macular Edema

Currently open trials in the same condition.

NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
NCT06984822 — Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant · NA · recruiting
NCT07038967 — Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification · recruiting
NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
NCT06549023 — Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy · NA · recruiting

Other Santen SAS trials

Trials by the same sponsor.

NCT06514612 — LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) · Phase 3 · recruiting
NCT04701086 — 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis · NA · completed
NCT04685109 — 3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis · NA · active not recruiting
NCT04144413 — 3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin) · Phase 3 · completed
NCT04133311 — A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00665106 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Santen SAS
Last refreshed: 26 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00665106.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing