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Wet Macular DegenerationPhase 2NCT02571972

Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.

A Phase 2 study testing Dorzolamide-timolol in people with Wet Macular Degeneration and Age-related Macular Degeneration, run by Wills Eye at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in non-responders with wet age-related macular degeneration. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dorzolamide-timolol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
1 Feb 2015to 20 Dec 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina.
  • Volunteer patients age 18 years and older.
  • Healthy enough to participate in the study.
  • Willing and able to consent to participation in the study.
  • Diagnosis of wet age-related macular degeneration
  • Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period
  • Injection of the same anti-VEGF agent for at least two visits prior to study enrollment
  • Fixed interval between at least two visits prior to study enrollment

Who cannot join

  • History of uveitis
  • Any ophthalmic surgery within previous 6 months, including cataract extraction.
  • Any history of vitrectomy
  • History of any glaucoma drop usage or prior glaucoma surgery
  • Systemic diuretic or corticosteroid usage
  • Any contraindication (bradycardia, decompensated heart failure, or reactive
Show all 9Show fewer
  • airway disease) for topical use of a beta-blocker
  • Any history of sulfonamide allergy
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wills Eye Hospital / Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Effect of Topical Aqueous Suppressants on Response to Intravitreal Anti-vascular Endothelial Growth Factor Injections in Age-related Macular Degeneration (AMD), Retinal Vein Occlusions (RVO) or Diabetic Macular Edema (DME).

This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in non-responders with wet age-related macular degeneration.

Read the detailed description

Intravitreal anti-vascular endothelial growth factor (VEGF) agents, including bevacizumab, ranibizumab, and aflibercept, have become the gold standard treatment for neovascular age-related macular degeneration (AMD). Various treatment modalities using these agents have been proposed, including monthly, pro re nata, and treat-and-extend philosophies. Despite frequent and consistent treatment with anti-VEGF therapy, there is a subset of patients who are incomplete or non-responders and have persistent evidence of exudation on spectral-domain optical coherence tomography (SD-OCT), including subretinal fluid (SRF) and/or intraretinal edema.

While clearance of intravitreal anti-VEGF drugs is not completely understood, some studies have suggested that outflow through the anterior chamber may contribute. We hypothesized that by decreasing aqueous production, outflow may also be reduced which could delay the clearance of intravitreal drugs. As a result, we chose topical dorzolamide-timolol since it is a potent aqueous suppressant and is readily available due to its common use in the treatment of glaucoma. The current study aimed to evaluate the efficacy of topical dorzolamide-timolol on anatomic and visual outcomes in anti-VEGF non-responders with neovascular AMD.

Significance: The results of this study will help delineate whether topical aqueous suppression may be useful as adjuvant therapy in patients receiving chronic intravitreal anti-VEGF injections.

Being tested
Dorzolamide-timolol
Keywords
dorzolamide-timolol, topical aqueous suppression, neovascular age-related macular degeneration, macular edema, intravitreal injection, anti-vascular endothelial growth factor
Medical subject headings
Wet Macular Degeneration, Macular Degeneration, Retinal Vein Occlusion, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dorzolamide-timololDrug

    Also called Cosopt

    On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration

Study groups in NCT02571972
Study groupRoleWhat they receive
Dorzolamide-timololExperimental* On enrollment, eligible patients will have visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan and will then receive the same intravitreal pharmacologic agent administered at prior visit. * Subsequent follow-up visits will be at an identical interval to pre-enrollment visit intervals (4, 5, or 6 week intervals) for the study duration. * Each subsequent visit will consist of visual acuity testing, intraocular pressure, dilated fundoscopic examination, SD-OCT scan, and intravitreal injection of same pharmacologic agent as prior visits * At study conclusion, mean central macular thickness, maximum subretinal fluid height, and maximum pigment epithelial detachment height will be measured over the study period for all patients
Receives: Drug: Dorzolamide-timolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Central Subfield Thickness (CST)

    Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment

    Measured: 3 visits (8-12 weeks)

Secondary outcomes (3)

  1. Visual Acuity

    LogMAR Visual acuity on enrollment and final visit

    Measured: 3 visits (8-12 weeks)

  2. Maximum Subretinal Fluid Height

    Measurement based on SD-OCT

    Measured: 3 visits (8-12 weeks)

  3. Maximum Pigment Epithelial Detachment Height

    Measurement based on SD-OCT

    Measured: 3 visits (8-12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study start1 Feb 2015
  3. Primary completion30 Sep 2015
  4. Study completion20 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02571972
Sponsor's protocol ID
IRB#14-435
Status last verified
Dec 2019
First submitted
6 Oct 2015
Last updated
3 Dec 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Byeon SH, Kwon OW, Song JH, Kim SE, Park YS. Prolongation of activity of single intravitreal bevacizumab by adjuvant topical aqueous depressant (Timolol-Dorzolamide). Graefes Arch Clin Exp Ophthalmol. 2009 Jan;247(1):35-42. doi: 10.1007/s00417-008-0917-1. Epub 2008 Aug 6.

    PubMed 18682969

  • Sridhar J, Hsu J, Shahlaee A, Garg SJ, Spirn MJ, Fineman MS, Vander J. Topical Dorzolamide-Timolol With Intravitreous Anti-Vascular Endothelial Growth Factor for Neovascular Age-Related Macular Degeneration. JAMA Ophthalmol. 2016 Apr;134(4):437-43. doi: 10.1001/jamaophthalmol.2016.0045.

    PubMed 26914218

  • Obeid A, Hsu J, Ehmann D, Gao X, Sridhar J, Chiang A, Park CH, Ho AC. TOPICAL DORZOLAMIDE-TIMOLOL WITH INTRAVITREOUS ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR FOR RETINAL VEIN OCCLUSION: A PILOT STUDY. Retin Cases Brief Rep. 2021 Mar 1;15(2):120-126. doi: 10.1097/ICB.0000000000000752.

    PubMed 29864044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dorzolamide-timolol in people with Wet Macular Degeneration and Age-related Macular Degeneration, run by Wills Eye at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Central Subfield Thickness (CST) (time frame: 3 visits (8-12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02571972, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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