NCT02511613

Brief Summary

The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
withdrawn

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

Study Start

First participant enrolled

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

July 27, 2015

Last Update Submit

April 25, 2017

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution

Drug: Placebo Ophthalmic SolutionDrug: ranibizumab

Active

ACTIVE COMPARATOR

Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2%

Drug: Squalamine Lactate Ophthalmic Solution, 0.2%Drug: ranibizumab

Interventions

Squalamine Lactate Ophthalmic Solution, 0.2%DRUG

Squalamine Lactate Ophthalmic Solution, 0.2% administered BID

Also known as: Squalamine
Active
Placebo Ophthalmic SolutionDRUG

Placebo Ophthalmic Solution, administered BID

Also known as: Placebo
Placebo
ranibizumabDRUG

ranibizumab intravitreal injection

Also known as: Lucentis®
ActivePlacebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
  • Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
  • Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol

You may not qualify if:

  • Neovascularization secondary to any other condition than AMD in the study eye
  • Blood occupying greater than 50% of the AMD lesion, or blood \> 1.0 sq. mm underlying the fovea
  • PED without associated subretinal fluid and/or cystic retinal changes
  • Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
  • Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
  • Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Investigational Site

Beverly Hills, California, 90211, United States

Location

Investigational Site

Hagerstown, Maryland, 21740, United States

Location

Investigational Site

New York, New York, 10022, United States

Location

Investigational Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

squalamineRanibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Avner Ingerman, MD

    Ohr Pharmaceutical

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 30, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

US(4)