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Anti-VEGF Monoclonal Antibody

THR-149 dose level 1 for Diabetic Macular Edema (KALAHARI Trial)

Phase 2
Waitlist Available
Research Sponsored by Oxurion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 6
Awards & highlights

KALAHARI Trial Summary

This trial is to study the effects of a new drug, THR-149, on patients with macular degeneration. Part A is to select the dose, and Part B is to compare the new drug to aflibercept, which is the current standard of care.

Eligible Conditions
  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • Diabetes

KALAHARI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
Secondary outcome measures
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Mean change in BCVA ETDRS letter score from Baseline, by study visit
Mean change in central subfield thickness (CST) from Baseline, by study visit

KALAHARI Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: THR-149 dose level 3Experimental Treatment1 Intervention
Group II: THR-149 dose level 2Experimental Treatment1 Intervention
Group III: THR-149 dose level 1Experimental Treatment1 Intervention
Group IV: THR-149 + shamExperimental Treatment1 Intervention
Group V: THR-149 + aflibercept flip-overExperimental Treatment1 Intervention
Group VI: Aflibercept + shamActive Control1 Intervention
Group VII: Aflibercept + THR-149 flip-overActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THR-149 dose level 1
2020
Completed Phase 2
~140
THR-149 dose level 3
2020
Completed Phase 2
~140
THR-149 0.13mg
2020
Completed Phase 2
~130
THR-149 dose level 2
2020
Completed Phase 2
~140
THR-149 0.13mg + aflibercept 2mg
2020
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

OxurionLead Sponsor
4 Previous Clinical Trials
616 Total Patients Enrolled
Clinical DepartmentStudy DirectorOxurion
9 Previous Clinical Trials
248 Total Patients Enrolled

Media Library

Aflibercept (Anti-VEGF Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT04527107 — Phase 2
Diabetic Macular Edema Research Study Groups: THR-149 dose level 1, THR-149 dose level 3, Aflibercept + sham, THR-149 + aflibercept flip-over, Aflibercept + THR-149 flip-over, THR-149 dose level 2, THR-149 + sham
Diabetic Macular Edema Clinical Trial 2023: Aflibercept Highlights & Side Effects. Trial Name: NCT04527107 — Phase 2
Aflibercept (Anti-VEGF Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527107 — Phase 2
Diabetic Macular Edema Patient Testimony for trial: Trial Name: NCT04527107 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What do doctors usually prescribe THR-149 for?

"The THR-149 selected dose level is a popular choice for treating wet age-related macular degeneration (wamd). It can also be used to intervene in other conditions like macular edema, diabetic macular edema (dme), and general macular degeneration."

Answered by AI

Will the dosage of THR-149 have any harmful effects on test subjects?

"Although there is some data to support the safety of THR-149 at this dosage, it received a score of 2 because clinical efficacy has not been observed yet."

Answered by AI

Are there several clinics running this clinical trial in the city?

"31 different medical centres are participating in this study, these include Retina Associates of South Texas, P.A. in San Antonio, Tenneesse Retina in Nashville, and California Retina Consultants in Oxnard."

Answered by AI

Are there still opportunities for people to join this trial as participants?

"The clinical trial, which is currently open for enrollment, was first posted on 7/31/2020 and last edited on 10/28/2022. The study will be conducted at 31 sites across the globe and is looking for 126 participants in total."

Answered by AI

How many people are currently enrolled in this clinical trial?

"That is accurate. According to the latest information available on clinicaltrials.gov, this trial was posted on 7/31/2020 and is still actively recruiting patients. The study requires 126 participants who can be found at the 31 different sites."

Answered by AI

What other medical studies have looked at the effects of THR-149 before?

"THR-149 was first studied in 2013 and has completed 233 clinical trials thus far. As of now, there are 51 active studies with a significant number of these taking place in San Antonio, Texas."

Answered by AI

Who else is applying?

What state do they live in?
California
Louisiana
Florida
What site did they apply to?
Northern California Retina Vitreous Associates Medical Group, Inc.
Fort Lauderdale Eye Institute
MedEye Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I have dry AMD, and I have tried one injection. A sample.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. MedEye Associates: < 24 hours
  2. Houston Eye Associates: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
2020. "A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04527107.
~27 spots leftby May 2025
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