Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02398500
Other study ID # LMG324-2201
Secondary ID 2014-005214-37
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date July 22, 2015
Est. completion date May 20, 2016

Study information

Verified date June 2019
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this first-in-human study is to evaluate the safety and tolerability of single ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in neovascular age-related macular degeneration (nvAMD) subjects. Enrollment will be expanded at a safe and tolerated dose in treatment naïve nvAMD subjects to compare a single intravitreal (IVT) dose of LMG324 to ranibizumab 0.5 mg administered every 4 weeks for change from baseline in best-corrected visual acuity (BCVA) at Week 12 (Day 85).


Description:

The study will start with a single dose ascending (SAD) phase. LMG324 will be administered on Day 1 with no further treatment until implementation of standard of care (SoC) therapy. SoC therapy is ranibizumab 0.5 mg administered per label. Dose groups will be implemented sequentially to allow for safety review between the current and subsequent dose group. All treatments will be open-label, including ranibizumab used as SoC therapy.

In the enrollment expansion phase, subjects randomized to LMG324 arm will receive a single LMG324 IVT injection on Day 1 followed by sham (fake) IVT injections until implementation of SoC therapy. After implementation, SoC therapy will be applied monthly with sham injections applied at the interim planned visits. The enrollment expansion phase may start at a selected dose level whilst the dose escalation phase is still ongoing.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date May 20, 2016
Est. primary completion date February 29, 2016
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Must give written informed consent, be able to make the required study visits and follow instructions.

- Best corrected visual acuity (BCVA) of 34 letters (approximately 20/200 Snellen or better) in the non-study eye.

SAD population only:

- Subject's study eye must have a choroidal neovascularization (CNV) lesion due to age-related macular degeneration (AMD), either treatment naïve or previously treated, that can be expected to benefit, in the opinion of the investigator, from anti-vascular endothelial growth factor (anti-VEGF) therapy.

- Previously treated eyes must have a history of least 3 administrations of any intravitreal (IVT) anti-VEGF therapeutic for the treatment of CNV with the last injection administered = 1 month prior to the planned administration of the study drug.

Enrollment expansion population only

- Subject's study eye must have untreated and active CNV lesion due to AMD.

- BCVA, between 73 - 23 letters, inclusive (approximate Snellen equivalent 20/40 - 20/320) in the study eye.

Exclusion Criteria:

SAD and enrollment expansion population

- Both eyes: any active ocular or periocular infection or active intraocular inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis).

- Study eye: current vitreous hemorrhage or a history of rhegmatogenous retinal detachment.

- Study eye: uncontrolled glaucoma (intraocular pressure [IOP] >25 mmHg on medication or according to Investigator's judgment).

SAD population only

- Presence of any contraindications, in the Investigator's opinion, to IVT anti-VEGF therapeutic administration.

Enrollment expansion population only

- Study eye: subject has received any approved or investigational treatment for exudative (wet) AMD other than vitamin supplements.

- Study eye: any current or history of macular or retinal disease other than exudative AMD

- Study eye: serous pigment epithelial detachment (PED) under the foveal center or retinal pigment epithelium (RPE) tear/rip.

- Study eye: any concurrent intraocular condition (eg, cataract, diabetic retinopathy) that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study.

- Study eye: other ocular diseases that, in the opinion of the Investigator, can compromise the visual acuity

- Study eye: Surgery, as specified in the protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
LMG324
IVT injection
Ranibizumab 0.5 mg
IVT injection
Sham
Fake injection used for masking purposes

Locations

Country Name City State
United States Call Alcon Call Center for Trial Locations Fort Worth Texas

Sponsors (2)

Lead Sponsor Collaborator
Alcon Research Novartis Institutes for BioMedical Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in best corrected visual acuity (BCVA) at Day 85 Baseline, Day 85
Secondary Percentage of LMG324-treated subjects with no identified SoC treatment need up to and including Day 85 Up to Day 85
Secondary Best Corrected Visual Acuity (BCVA) Up to Day 169
Secondary Central subfield thickness total (CSFTtot) Up to Day 169
Secondary Central subfield thickness neuro-retina (CFSTnr) Up to Day 169
Secondary Lesion thickness Up to Day 169
Secondary Subretinal fluid with foveal involvement (SRFfi) thickness Up to Day 169
Secondary Retinal pigment epithelial detachment with foveal involvement (PEDfi) thickness Up to Day 169
Secondary Area of lesion (associated with CNV) Up to Day 169
Secondary Area of CNV within a lesion Up to Day 169
Secondary Area under the plasma concentration-time curve from time zero to infinity (AUCinf) Up to Day 169
Secondary Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) Up to Day 169
Secondary Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t) Up to Day 169
Secondary Maximum observed maximum plasma concentration (Cmax) Up to Day 169
Secondary Time to reach the maximum observed plasma concentration (Tmax) Up to Day 169
Secondary Observed maximum plasma concentration following drug administration, by dose (Cmax/D) Up to Day 169
Secondary Area under the plasma concentration-time curve divided by dose (AUC/D) Up to Day 169
Secondary Frequency of subjects with anti-LMG324 antibodies Up to Day 169
See also
  Status Clinical Trial Phase
Completed NCT01694680 - Intervention Trial in Early Age-related Macular Degeneration N/A
Completed NCT01224847 - Intravitreal Injection Anesthesia - Comparison of Different Topical Agents N/A
Withdrawn NCT04697953 - Efficacy and Safety of Brolucizumab 6mg in a Treat and Extend Regimen in Patients With Neovascular Age-Related Macular Degeneration (nAMD) With Prior Anti-VEGF Exposure (PEREGRINE) Phase 3
Completed NCT05037396 - Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
Completed NCT00647439 - Genetics and Markers of Degenerative and Inflammatory Eye Diseases
Terminated NCT00902785 - A Study Of Early Markers Of Choroidal Neovascularization Phase 4
Terminated NCT02348359 - X-82 to Treat Age-related Macular Degeneration Phase 2
Recruiting NCT03690505 - Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place N/A
Recruiting NCT03577041 - Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context
Completed NCT05082415 - Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Completed NCT02445313 - Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
Recruiting NCT00354445 - A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD Phase 4
Completed NCT05111743 - Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Completed NCT05110209 - Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Agerelated Macular Degeneration (AMD) Who Received Anti-VEGF Agents (IRIS Registry)
Completed NCT05146687 - Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
Not yet recruiting NCT05780931 - Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
Recruiting NCT04292080 - Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy Phase 2
Recruiting NCT03859245 - Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention N/A
Completed NCT02022540 - Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD Phase 1
Completed NCT02585401 - Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada N/A