NCT02867735

Brief Summary

To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

August 9, 2016

Last Update Submit

April 8, 2022

Conditions

Macular EdemaDiabetic Macular EdemaNeovascular Age-related Macular DegenerationRetinal Vein Occlusions

Keywords

Macular EdemaDiabetic Macular Edema (DME)Neovascular age-related Macular Degeneration(AMD)Retinal Vein Occlusions (RVO)

Outcome Measures

Primary Outcomes (1)

  • Number Of participants with Adverse Events as a measure of Safety and Tolerability

    To evaluate the safety and tolerability of LKA651 by reviewing any adverse events after medical or ophthalmic examinations that are possibly or probably related to study drug.

    Day 1 through study completion

Secondary Outcomes (2)

  • Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)

    Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85

  • Pharmacokinetics of Single Dose of LKA651 - Cmax

    Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85

Study Arms (2)

LKA651

EXPERIMENTAL
Drug: LKA651

Sham Comparator

SHAM COMPARATOR
Other: Sham Comparator

Interventions

LKA651DRUG

Interventional

LKA651
Sham ComparatorOTHER
Sham Comparator

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO
  • The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)
  • Vital signs as specified within the protocol

You may not qualify if:

  • Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage
  • Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C \> or = 12% at screening
  • other ocular conditions as specified in the protocol
  • systemic conditions as specified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Pasadena, California, 91105-3153, United States

Location

Novartis Investigative Site

Fort Myers, Florida, 33901, United States

Location

Novartis Investigative Site

Miami, Florida, 33143, United States

Location

Novartis Investigative Site

Winter Haven, Florida, 33880, United States

Location

Novartis Investigative Site

Augusta, Georgia, 30909, United States

Location

Novartis Investigative Site

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 16, 2016

Study Start

September 21, 2016

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

PR(1)US(5)