Post-surgical Cystoid Macular Edema (PSCME)Phase 2/3TEMPESTNCT01769352

Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

A Phase 2/3 study testing PredA + Kelac in people with Post-surgical Cystoid Macular Edema (PSCME), run by Johns Hopkins University 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

The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Post-surgical Cystoid Macular Edema (PSCME)
What is being tested?: PredA + Kelac
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Apr 2016
Phase: Phase 2/3
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

Age more than or equal to 18 years
Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.

Who cannot join

Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
Pre-existing diagnosis of glaucoma in the study eye
Inability to comply with study or follow up procedures
Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).

Trial locations and contacts

1 site in 1 country.

United States1 site

Wilmer Eye Institute
Baltimore, Maryland, 21287

Other trials in United States

About this study

The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.

Read the detailed description

Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.

Conditions: Post-surgical Cystoid Macular Edema (PSCME)
Being tested: PredA + Kelac
Keywords: cystoid macular edema
Medical subject headings: Macular Edema

What participants receive

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

PredA + KelacDrug
Also called Acular, Acuvail, Pred Forte, Omnipred, Pred Mild
At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.

Study groups in NCT01769352
Study group	Role	What they receive
PredA q1h WA + Kelac qid	Active comparator	Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid) Receives: Drug: PredA + Kelac
PredA qid + Kelac qid	Active comparator	Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid) Receives: Drug: PredA + Kelac

What is being measured

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

Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
Measured: Baseline and Week 12

Secondary outcomes (5)

Mean Change in Central Subfield Thickness at Week 12 From Baseline
Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline
Measured: Baseline and Week 12
Mean Change in Intraocular Pressure at Week 12 From Baseline
Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
Measured: Baseline and Week 12
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
Measured: Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48
Measured: Week 12 and Week 48
Mean Change in Intraocular Pressure Between Week 12 and Week 24
Mean Change in Intraocular Pressure (IOP) between week 12 and week 24
Measured: Week 12 and Week 48

Timeline

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

Aug 2012Apr 2016

First posted16 Jan 2013 (estimated)
Study startAug 2012
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Post-surgical Cystoid Macular Edema (PSCME)Studies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01769352
Sponsor's protocol ID: NA_00074523
Acronym: TEMPEST
Status last verified: Aug 2017
First submitted: 14 Jan 2013
Last updated: 15 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
ClinicalTrials.gov ID: NCT01769352
Acronym / sponsor ID: TEMPEST / NA_00074523
Conditions: Post-surgical Cystoid Macular Edema (PSCME)
Keywords: cystoid macular edema
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: Aug 2012
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 16 Jan 2013 (estimated)
Results: Posted 15 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PredA q1h WA + Kelac qid	Active comparator	Drug: PredA + KelacPrednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
PredA qid + Kelac qid	Active comparator	Drug: PredA + KelacPrednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age more than or equal to 18 years
Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.

Key exclusion criteria (5 listed)

Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
Pre-existing diagnosis of glaucoma in the study eye
Inability to comply with study or follow up procedures
Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PredA + KelacAlso: Acular, Acuvail, Pred Forte, Omnipred, Pred MildAt week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.	Drug	PredA q1h WA + Kelac qid, PredA qid + Kelac qid

Primary outcome

Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
Time frame: Baseline and Week 12
Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.

5 secondary outcomes

Mean Change in Central Subfield Thickness at Week 12 From Baseline
Time frame: Baseline and Week 12
Mean Change in Intraocular Pressure at Week 12 From Baseline
Time frame: Baseline and Week 12
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
Time frame: Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
Time frame: Week 12 and Week 48
Mean Change in Intraocular Pressure Between Week 12 and Week 24
Time frame: Week 12 and Week 48

Results and safety

Results posted to the registry on 15 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - Group 1	13	13
Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2	12	12
Post-Other Surgery CME (PredA q1h + Kelac Qid) - Group 1	9	9
Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2	8	8

Primary outcome: Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: letters

Measure	Post-Cataract Surgery Macular Edema- Group 1 n = 13	Post-Cataract Surgery Macular Edema- Group 2 n = 12	Post-Other Surgery Macular Edema- Group 1 n = 9	Post-Other Surgery Macular Edema- Group 2 n = 8
Value	10.6 (2.6)	7.8 (3.4)	13.1 (3.4)	9.4 (3.6)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prednisolone Acetate Every 1 Hour While Awake (Group 1)	5 of 22 (22.7%)	6 of 22 (27.3%)	0 of 22
Prednisolone Acetate Four Times a Day (Group 2)	4 of 20 (20%)	9 of 20 (45%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter A Campochiaro, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PredA + Kelac in people with Post-surgical Cystoid Macular Edema (PSCME), run by Johns Hopkins University 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 4 inclusion and 5 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 15 Sep 2017. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Sep 2017). 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 Change in Best-Corrected Visual Acuity at Week 12 From Baseline (time frame: Baseline and Week 12). 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 NCT01769352.

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 15 Sep 2017.