Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects - Full Text View

Purpose

To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: DE-122 Injectable Solution	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Outcomes Assessor Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Santen Inc.:

Primary Outcome Measures:

Mean change from baseline in best corrected visual acuity (BCVA) at Week 24 [ Time Frame: Week 24 ]
BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint.


Estimated Enrollment:	51
Actual Study Start Date:	July 5, 2017
Estimated Study Completion Date:	March 2019
Estimated Primary Completion Date:	February 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low Dose DE-122 + Lucentis multi-intravitreal injection of low dose DE-122 and Lucentis	Drug: DE-122 Injectable Solution Subjects will receive 6 monthly intravitreal injections of DE-122 (Low dose or High Dose) or Sham in the study eye, in combination with Lucentis.
Experimental: High Dose DE-122 + Lucentis multi-intravitreal injection of high dose DE-122 and Lucentis	Drug: DE-122 Injectable Solution Subjects will receive 6 monthly intravitreal injections of DE-122 (Low dose or High Dose) or Sham in the study eye, in combination with Lucentis.
Sham Comparator: Sham + Lucentis multi-intravitreal injection of Sham and Lucentis	Drug: DE-122 Injectable Solution Subjects will receive 6 monthly intravitreal injections of DE-122 (Low dose or High Dose) or Sham in the study eye, in combination with Lucentis.

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide signed written informed consent
Diagnosis of active choroidal neovascularization secondary to wet AMD
BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye
BCVA of 25 ETDRS letters (20/320) or better in the fellow eye

Exclusion Criteria:

[Ocular]

Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1 and throughout the study
Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
Need for ocular surgery in the study eye during the course of the study
Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform examinations

[Non-ocular]

Allergy or hypersensitivity to study drug product, fluorescein dye or other study related procedures and medications
Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study
Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
Unable to comply with study procedures or follow-up visits

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211234

Contacts


Contact: Santen Incorporated Clinical Operations	+1-415-268-9100	clinicaltrials@santeninc.com

Locations


Philippines
Asian Eye Institute	Not yet recruiting
Makati City, Philippines
Peregrine Eye and Laser Institute	Recruiting
Makati City, Philippines
The Medical City	Not yet recruiting
Pasig City, Philippines
St. Luke's Medical center Quezon City	Not yet recruiting
Quezon City, Philippines

Sponsors and Collaborators

Santen Inc.

More Information


Responsible Party:	Santen Inc.
ClinicalTrials.gov Identifier:	NCT03211234 History of Changes
Other Study ID Numbers:	36-002
Study First Received:	July 6, 2017
Last Updated:	July 6, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Immunologic Factors	Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on July 11, 2017