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HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566445
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Gyroscope Therapeutics

Brief Summary:
The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Drug: GT005: Dose 1 Drug: GT005: Dose 2 Phase 2

Detailed Description:

This is a Phase 2, open-label, outcomes-assessor masked, multicentre, randomised, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.

The trial includes a screening period of up to 8 weeks and a 48-week study period.

Subjects will be randomised to two groups; GT005 or the untreated control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase II, open-label, outcomes-assessor masked, multicentre, randomised, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcome Assessor). The overall objectives of the study are to evaluate the safety and efficacy (anatomical and functional visual outcomes) of two doses of GT005 in genetically defined subjects with GA due to AMD.
Primary Purpose: Treatment
Official Title: HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Actual Study Start Date : November 11, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GT005 Dose 1
Approximately 60 subjects are planned, with subjects randomised to GT005 Dose 1.
Drug: GT005: Dose 1
The study will test two doses of GT005; Dose 1 and Dose 2.

Experimental: GT005 Dose 2
Approximately 60 subjects are planned, with subjects randomised to GT005 Dose 2.
Drug: GT005: Dose 2
The study will test two doses of GT005; Dose 1 and Dose 2.

No Intervention: Untreated control
Approximately 60 subjects are planned, with subjects randomised to untreated control.



Primary Outcome Measures :
  1. Progression of geographic atrophy [ Time Frame: 48 weeks ]
    The change from baseline to Week 48 in GA area as measured by fundus fluorescence (FAF)


Secondary Outcome Measures :
  1. Frequency of treatment emergent adverse events (TEAEs) [Safety and Tolerability of GT005] [ Time Frame: 48 weeks ]
  2. Change on ophthalmic examination [Safety and Tolerability of GT005] [ Time Frame: 48 weeks ]
  3. Change in imaging modalities [Safety and Tolerability of GT005] [ Time Frame: 48 weeks ]
  4. Change in best corrected visual acuity (BCVA) [Safety and Tolerability of GT005] [ Time Frame: 48 weeks ]
  5. Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 48 weeks ]
    Change in retinal microstructures on spectral domain optical coherence tomography (SD-OCT)

  6. Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 48 weeks ]
    Change in area of nascent GA on SD-OCT

  7. Evaluation of the effect of GT005 on retinal anatomical measures [ Time Frame: 48 weeks ]
    Change in GA morphology on colour fundus photography (CFP)

  8. Evaluation of the effect of GT005 on functional measures [ Time Frame: 48 weeks ]
    Macular sensitivity as assessed by mesopic microperimetry

  9. Evaluation of the effect of GT005 on functional measures [ Time Frame: 48 weeks ]
    Change in BCVA Score via the early treatment for diabetic retinopathy (ETDRS) chart

  10. Evaluation of the effect of GT005 on functional measures [ Time Frame: 48 weeks ]
    Change in low luminance difference (LLD) via the ETDRS chart

  11. Evaluation of the effect of GT005 on functional vision [ Time Frame: 48 weeks ]
    Change in reading performance as assessed by Minnesota low-vision reading test (MNRead) chart

  12. Evaluation of the effect of GT005 on functional vision [ Time Frame: 48 weeks ]
    Change in functional reading independence index (FRI index)

  13. Evaluation of the effect of GT005 on patient-reported outcomes [ Time Frame: 48 weeks ]
    Change in quality of life measured on the Visual Functioning Questionnaire-25 (VFQ-25)

  14. Evaluation of the effects of GT005 on the progression of GA, in each genetically defined subgroup(s) [ Time Frame: 48 weeks ]
    Change from baseline to Week 48 in GA area as measured by FAF



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able and willing to give written informed consent.
  2. Age ≥55 years.
  3. Have a clinical diagnosis of bilateral GA secondary to AMD as determined by the Investigator.
  4. GA lesion(s) within an acceptable size on FAF, in the study eye.
  5. The GA lesion in the study eye must reside completely within the FAF image.
  6. Have a BCVA of 34 letters (6/60 or 20/200 Snellen acuity equivalent), using ETDRS charts, in the study eye.
  7. Meet one of the pre-specified AMD genetic subgroup criteria.
  8. Able to attend all study visits and complete the study procedures.
  9. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation or provide documentation of being surgically sterilised.

Exclusion Criteria:

  1. Carriers of excluded genetic variants.
  2. Have evidence or history of CNV in either eye.
  3. Presence of moderate/severe or worse non-proliferative, diabetic retinopathy in the study eye.
  4. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye.
  5. Have clinically significant cataract that may require surgery during the study period in the study eye.
  6. Presence of moderate to severe glaucomatous optic neuropathy, uncontrolled IOP, use of two or more topical agents to control IOP; or a history of glaucoma-filtering surgery in the study eye.
  7. Axial myopia of greater than -8 diopters in the study eye.
  8. Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the age-related eye disease study (AREDS) formula.
  9. Have received a gene or cell therapy at any time.
  10. Have a contraindication to the corticosteroid regimen.
  11. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant.
  12. Have a history or presence of cutaneous squamous cell carcinoma.
  13. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566445


Contacts
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Contact: Gyroscope Gyroscope Therapeutics +441438532142 ext +441438532142 clinicaltrials@gyroscopetx.com

Locations
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United States, California
Retina Consultants San Diego Recruiting
Poway, California, United States, 92064
United States, Iowa
Wolfe Eye Clinic Recruiting
West Des Moines, Iowa, United States, 50266
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New York
Harkness Eye Institute Recruiting
New York, New York, United States, 10032
Retina Associates of Western NY Recruiting
Rochester, New York, United States, 14620
United States, Ohio
Cincinnati Eye Institute Not yet recruiting
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Wills Eye Clinic Recruiting
Philadelphia, Pennsylvania, United States, 19107
Germany
Eberhard Karls University of Tübingen Recruiting
Tübingen,, Germany, 72074
United Kingdom
Sunderland Eye Infirmary Recruiting
Sunderland, United Kingdom, SR2 9HP
Sponsors and Collaborators
Gyroscope Therapeutics
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Responsible Party: Gyroscope Therapeutics
ClinicalTrials.gov Identifier: NCT04566445    
Other Study ID Numbers: GT005-03
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gyroscope Therapeutics:
Dry age-related macular degeneration
Geographic atrophy
Retinal disease
Eye disease
Retinal degeneration
Macular atrophy
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases