Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | May 23, 2018 |
| End Date: | March 2020 |
| Contact: | Cassie Cone, BA |
| Email: | cassandra.cone@houstonretina.com |
| Phone: | 713-394-7537 |
Study eyes will be assigned randomly (1:1 ratio) to one of the following 2 treatment arms.
Randomization of PDR subjects will be limited to 50% of each arm.
Group 1- Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects
will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48,
subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day,
central reading center (CRC) determined DRSS level.
Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level
improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS
fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS
Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step
DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative
to screening/baseline DRSS, and PDR is quiescent according to the treating investigator.
Treatment with IAI will be reinitiated if a 1 step worsening of DRSS occurs compared to best
DRSS score achieved, determined by CRC evaluation of OPTOS fundus photos (this equates to
less than a 2 step DRSS improvement compared to baseline DRSS). If such worsening is
detected, the subject would resume monthly IAI until a greater than or equal to 2 step DRSS
improvement compared to baseline is achieved, as determined by CRC assessment of OPTOS fundus
photos. In addition, retreatment will also be re-started if new onset neovascularization is
identified and is continued until the PDR is quiescent according to the treating
investigator.
Group 2 - Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects
will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48,
subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day,
CRC determination of DRSS initially, and subsequently of leakage index.
Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level
improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS
fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS
Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step
DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative
to screening/baseline DRSS, and PDR is quiescent according to the treating investigator.
Leakage index as determined by CRC assessment of OPTOS wide field (WF) fluorescein
angiography (FA) at the visit at which a greater than or equal to 2 step DRSS level
improvement is achieved will be considered the threshold. Treatment with IAI will be
reinitiated if the leakage index increases to 33% above the individual subject threshold
leakage index level as determined by CRC evaluation of OPTOS WF-FA. If such worsening is
detected, the subject would resume monthly IAI until the threshold leakage index as
determined by CRC assessment of OPTOS WF-FA is reached. In addition, retreatment will also be
re-started if new onset neovascularization is identified and is continued until the PDR is
quiescent according to the treating investigator.
If images of insufficient quality are unable to be obtained, in Group 1 or Group 2, subjects
will undergo treatment with IAI at principal investigators discretion or designee.
Subjects can have both eyes in the study, if eligibility is met. If both eyes are eligible,
one eye will be randomized to group 1 while the other is randomized to group 2. If only one
eye is eligible IAI will be provided for the fellow eye as needed according to the treating
investigator.
Randomization of PDR subjects will be limited to 50% of each arm.
Group 1- Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects
will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48,
subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day,
central reading center (CRC) determined DRSS level.
Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level
improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS
fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS
Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step
DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative
to screening/baseline DRSS, and PDR is quiescent according to the treating investigator.
Treatment with IAI will be reinitiated if a 1 step worsening of DRSS occurs compared to best
DRSS score achieved, determined by CRC evaluation of OPTOS fundus photos (this equates to
less than a 2 step DRSS improvement compared to baseline DRSS). If such worsening is
detected, the subject would resume monthly IAI until a greater than or equal to 2 step DRSS
improvement compared to baseline is achieved, as determined by CRC assessment of OPTOS fundus
photos. In addition, retreatment will also be re-started if new onset neovascularization is
identified and is continued until the PDR is quiescent according to the treating
investigator.
Group 2 - Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects
will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48,
subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day,
CRC determination of DRSS initially, and subsequently of leakage index.
Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level
improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS
fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS
Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step
DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative
to screening/baseline DRSS, and PDR is quiescent according to the treating investigator.
Leakage index as determined by CRC assessment of OPTOS wide field (WF) fluorescein
angiography (FA) at the visit at which a greater than or equal to 2 step DRSS level
improvement is achieved will be considered the threshold. Treatment with IAI will be
reinitiated if the leakage index increases to 33% above the individual subject threshold
leakage index level as determined by CRC evaluation of OPTOS WF-FA. If such worsening is
detected, the subject would resume monthly IAI until the threshold leakage index as
determined by CRC assessment of OPTOS WF-FA is reached. In addition, retreatment will also be
re-started if new onset neovascularization is identified and is continued until the PDR is
quiescent according to the treating investigator.
If images of insufficient quality are unable to be obtained, in Group 1 or Group 2, subjects
will undergo treatment with IAI at principal investigators discretion or designee.
Subjects can have both eyes in the study, if eligibility is met. If both eyes are eligible,
one eye will be randomized to group 1 while the other is randomized to group 2. If only one
eye is eligible IAI will be provided for the fellow eye as needed according to the treating
investigator.
Inclusion Criteria:
1. Men or Women > 18 years of age with type 1 or II diabetes mellitus
2. Diabetic Retinopathy, DRSS Level 47A to 71A, as assessed by CRC (enrollment of PDR
levels will be limited to 50% of the total population)
3. BCVA in the study eye better than 20/800
Exclusion Criteria:
1. Any prior systemic anti-VEGF treatment or IVT anti-search vascular endothelial growth
factor (VEGF) treatment in the study eye within 24 weeks of screening/baseline
2. Any intravitreal or peribulbar corticosteroids in the study eye within 12 weeks of
screening/baseline
3. Any prior treatment with Ozurdex or Iluvien in the study eye
4. SD-OCT central subfield thickness (CST) > 320 µm in the study eye
5. Central DME causing visual acuity loss, in which treatment can not be safely deferred
for at least 6 months, in the investigator's judgment
6. Current visually significant vitreous hemorrhage in the study eye. Vitreous hemorrhage
is allowed as long as DRSS level is 71A or lower.
7. History of panretinal photocoagulation (PRP) in the study eye
8. History of vitrectomy surgery in the study eye
9. Cataract surgery in the study eye within 8 weeks of screening/baseline
10. Pregnant or breast-feeding women
11. Sexually active men* or women of childbearing potential** who are unwilling to
practiceadequate contraception during the study (adequate contraceptive measures
include stable use of oral contraceptives or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening/baseline;
intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus
contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or
jelly).
* Contraception is not required for men with documented vasectomy.
** Postmenopausal women must be amenorrheic for at least 52 weeks in order not to be
considered of childbearing potential. Pregnancy testing and contraception are not
required for women with documented hysterectomy or tubal ligation.
12. If currently receiving diaylisis, must have started treatment more than 12 weeks prior
to screening/baseline
13. Uncontrolled blood pressure (defined as > 190/110 mm Hg systolic/diastolic, while
seated)
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