Campbell, California 95008

  • related Macular Degeneration

Purpose:

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is 2 years


Study summary:

Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted in 2 periods (Year 1 and Year 2). Year 1 (Screening/Baseline to Week 52): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio: - Squalamine lactate ophthalmic solution, 0.2% BID (Years 1 and 2) + ranibizumab every 4 weeks (Year 1) and PRN ranibizumab (as needed, Year 2) - Placebo ophthalmic solution BID (Years 1 and 2) + monthly ranibizumab every 4 weeks (Year 1) and PRN ranibizumab (Year 2), based on optical coherence tomography (OCT)-guided re-treatment criteria


Criteria:

Inclusion Criteria: - Age ≥ 50 years - A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA) - Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm - Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart) Exclusion Criteria: - 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 - Pigment epithelial detachment (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


Study is Available At:


Original ID:

OHR-1601


NCT ID:

NCT02727881


Secondary ID:


Study Acronym:

MAKO


Brief Title:

Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD


Official Title:

OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

50 Years


Maximum Age:

110 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohr Pharmaceutical Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

650


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Avner Ingerman, MD
Study Director
Ohr Pharmaceutical
Primary Contact:Avner Ingerman, MD
2126828452 ext. 113
2126828452
aingerman@ohrpharmaceutical.com
Backup Contact:Shawn Shearn, MSc.
2126828452 ext. 113
2126828452
sshearn@ohrpharmaceutical.com

Study Dates

Start Date:April 2016
Completion Date:April 2019
Completion Type:Anticipated
Primary Completion Date:December 2017
Primary Completion Type:Anticipated
Verification Date:August 2016
Last Changed Date:August 5, 2016
First Received Date:March 28, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure:Functional change in visual acuity
Time Frame:9 months
Safety Issues:False
Description:Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration
Outcome Type:Secondary Outcome
Measure:Functional changes in visual acuity
Time Frame:12 months
Safety Issues:False
Description:Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on change in visual function as assessed by ETDRS BCVA in subjects with Age-Related Macular Degeneration

Study Interventions

Intervention Type:Drug
Name:ranibizumab
Description:ranibizumab
Arm Name:Squalamine solution, 0.2% BID
Other Name:Lucentis
Intervention Type:Drug
Name:Placebo Ophthalmic solution
Description:Placebo Ophthalmic solution
Arm Name:Placebo solution BID
Other Name:placebo
Intervention Type:Drug
Name:Squalamine lactate ophthalmic solution, 0.2%
Description:Squalamine lactate ophthalmic solution, 0.2%
Arm Name:Squalamine solution, 0.2% BID
Other Name:active

Study Arms

Study Arm Type:Experimental
Arm Name:Squalamine solution, 0.2% BID
Description:Squalamine lactate ophthalmic solution, 0.2% bis in die (BID) (Years 1 and 2) + ranibizumab every 4 weeks (Year 1) and PRN (pro re nata, as needed) ranibizumab (Year 2)
Study Arm Type:Placebo Comparator
Arm Name:Placebo solution BID
Description:Placebo ophthalmic solution BID (Years 1 and 2) + monthly ranibizumab every 4 weeks (Year 1) and PRN (pro re nata, as needed) ranibizumab (Year 2)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ohr Pharmaceutical Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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